<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02219802</url>
  </required_header>
  <id_info>
    <org_study_id>NL48495.100.14</org_study_id>
    <nct_id>NCT02219802</nct_id>
  </id_info>
  <brief_title>Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial Infarction</brief_title>
  <acronym>REVELATION</acronym>
  <official_title>Revascularization With Paclitaxel-coated Balloon Angioplasty Versus Drug-eluting Stenting in Acute Myocardial Infarction - a Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Onze Lieve Vrouwe Gasthuis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biotronik SE &amp; Co. KG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Volcano Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Onze Lieve Vrouwe Gasthuis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and&#xD;
      drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in&#xD;
      primary percutaneous coronary intervention (PPCI). However, this did not result in a&#xD;
      reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of&#xD;
      the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility&#xD;
      of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term&#xD;
      clinical results, with sustained safety and efficacy at 12 months follow-up. To date little&#xD;
      is known about the long-term effects of this treatment modality in STEMI. Besides,&#xD;
      angiographic follow-up is of great clinical importance by giving insight on the treated&#xD;
      infarct lesion and to assess the functional angioplasty result.&#xD;
&#xD;
      Objective: This randomized controlled, non-inferiority trial is mainly designed to&#xD;
      prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only&#xD;
      strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction&#xD;
      (STEMI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and&#xD;
      drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in&#xD;
      primary percutaneous coronary intervention (PPCI). However, this did not result in a&#xD;
      reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of&#xD;
      the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility&#xD;
      of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term&#xD;
      clinical results, with sustained safety and efficacy at 12 months follow-up. To date little&#xD;
      is known about the long-term effects of this treatment modality in STEMI. Besides,&#xD;
      angiographic follow-up is of great clinical importance by giving insight on the treated&#xD;
      infarct lesion and to assess the functional angioplasty result.&#xD;
&#xD;
      Objective: This randomized controlled, non-inferiority trial is mainly designed to&#xD;
      prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only&#xD;
      strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction&#xD;
      (STEMI).&#xD;
&#xD;
      Study design: This is a prospective, single center, non-inferiority, randomized controlled&#xD;
      trial.&#xD;
&#xD;
      Study population: All patients presenting with STEMI and suitable for PPCI.&#xD;
&#xD;
      Intervention: PPCI will be performed according to current guidelines. After thrombus&#xD;
      aspiration and pre-dilatation, randomization between a DCB only strategy (with bail-out&#xD;
      stenting if indicated) and DES will be done by 1:1 ratio. Concomitant medication will be&#xD;
      administered according current standards. Control coronary angiography, including measurement&#xD;
      of the fractional flow reserve (FFR) of the treated lesion(s), will be performed after 9&#xD;
      months.&#xD;
&#xD;
      Main study parameters/endpoints: The main study parameter is the fractional flow reserve at 9&#xD;
      months follow-up. Secondary study parameters include cardiac death, recurrent myocardial&#xD;
      infarction in the target vessel area and ischemia driven target lesion revascularisation at 9&#xD;
      months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fractional flow reserve (FFR)</measure>
    <time_frame>At 9 months follow-up</time_frame>
    <description>Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major adverse cardiac event (MACE)</measure>
    <time_frame>In-hospital, at 1 and 9 months follow-up and at 2, 3, 4 and 5 year follow-up.</time_frame>
    <description>Cardiac death (ARC); defined as any death in which a cardiac cause cannot be excluded.&#xD;
Recurrent MI in the target vessel area.&#xD;
Ischemia driven target lesion revascularization (PCI within 5 mm of the treated segment in case of balloon, or stent area borders in case of stent, or CABG of the target vessel).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: iFR</measure>
    <time_frame>At 9 months follow-up.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ST-segment resolution</measure>
    <time_frame>90 minutes after initial procedure</time_frame>
    <description>ST-segment resolution post-initial procedure at 90 minutes, defined as the ST-segment deviation resolution in only the single lead showing maximum deviation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-coronary artery bypass grafting major bleeding</measure>
    <time_frame>At 1 month follow-up</time_frame>
    <description>Intracranial, intraocular, intra-articular or retroperitoneal bleeding&#xD;
Access site bleed requiring intervention/surgery&#xD;
Hematoma ≥ 5 cm&#xD;
Hemoglobin (Hgb) ≥4 g/dL without an overt source&#xD;
Hgb ≥3 g/dL with an overt source&#xD;
Operation for bleeding&#xD;
Any blood transfusions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis</measure>
    <time_frame>During follow-up</time_frame>
    <description>Definite or confirmed stent thrombosis: Angiographic confirmation of vessel occlusion or thrombus formation within, or adjacent to, the stented segment or proven stent thrombosis at autopsy.&#xD;
Probable stent thrombosis: Unexplained death within 30 days or target vessel recurrent MI without angiographic confirmation.&#xD;
Possible stent thrombosis: Unexplained death after 30 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: TIMI flow</measure>
    <time_frame>At 9 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: late lumen loss</measure>
    <time_frame>At 9 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: minimal lumen diameter</measure>
    <time_frame>At 9 months follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angiographic endpoint: diameter stenosis</measure>
    <time_frame>At 9 months follow-up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Acute Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Drug-eluting stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment of infarct related laesion with a drug-eluting stent</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Drug-coated balloon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After treatment of the infarct related artery with a drug-coated ballon, an additional BMS is advised to be used in case of residual stenosis &gt; 50% or coronary artery dissection type &gt; B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Treatment according arm</intervention_name>
    <arm_group_label>Drug-coated balloon</arm_group_label>
    <arm_group_label>Drug-eluting stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction eligible for primary PCI:&#xD;
&#xD;
          -  &gt; 20 min of chest-pain and at least 1 mm ST-elevation in at least two contiguous&#xD;
             leads, a new left bundle branch block or a true posterior myocardial infarction&#xD;
             (confirmed by ECG or echocardiography)&#xD;
&#xD;
          -  Reperfusion is expected to be feasible within 12 hours after onset of complaints&#xD;
&#xD;
          -  Infarct related artery eligible for PPCI and:&#xD;
&#xD;
          -  De novo lesion in a native coronary artery&#xD;
&#xD;
          -  Reference-vessel diameter ≥ 2.5mm and ≤ 4mm&#xD;
&#xD;
          -  Without severe calcification&#xD;
&#xD;
          -  Without diameter stenosis of &gt;50% (by visual assessment) after thrombus aspiration and&#xD;
             pre-dilatation.&#xD;
&#xD;
        The protocol requires visualization, thrombus aspiration and pre-dilatation of the culprit&#xD;
        lesion before inclusion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years and &gt; 75 years&#xD;
&#xD;
          -  History of myocardial infarction&#xD;
&#xD;
          -  Known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin,&#xD;
             prasugrel and/or ticagrelor.&#xD;
&#xD;
          -  Participation in another clinical study, interfering with this protocol&#xD;
&#xD;
          -  Uncertain neurological outcome e.g. resuscitation&#xD;
&#xD;
          -  Intubation/ventilation&#xD;
&#xD;
          -  Cardiogenic shock prior to randomization&#xD;
&#xD;
          -  Known intracranial disease (mass, aneurysm, AVM, hemorrhagic CVA, ischemic CVA/TIA &lt; 6&#xD;
             months prior to inclusion or ischemic CVA with permanent neurological deficit)&#xD;
&#xD;
          -  Gastro-intestinal / urinary tract bleeding &lt; 2 months prior to inclusion&#xD;
&#xD;
          -  Refusal to receive blood transfusion&#xD;
&#xD;
          -  Planned major surgery within 6 weeks&#xD;
&#xD;
          -  Stent implantation &lt; 1 month prior to inclusion&#xD;
&#xD;
          -  Expected mortality from any cause within the next 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>R. J. van der Schaaf, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OLVG</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>R. J. van der Schaaf, MD, PhD</last_name>
    <phone>+31-20-5992387</phone>
    <email>r.j.vanderschaaf@olvg.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>N. S. Vos, MD</last_name>
    <phone>+13-20-5992387</phone>
    <email>n.s.vos@olvg.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Onze Lieve Vrouwe Gasthuis</name>
      <address>
        <city>Amsterdam</city>
        <zip>1091 AC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <investigator>
      <last_name>R. J. van der Schaaf, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <reference>
    <citation>Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.</citation>
    <PMID>12517460</PMID>
  </reference>
  <reference>
    <citation>Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9. doi: 10.1056/NEJM199911043411901.</citation>
    <PMID>10547403</PMID>
  </reference>
  <reference>
    <citation>Stone GW, Grines CL, Browne KF, Marco J, Rothbaum D, O'Keefe J, Hartzler GO, Overlie P, Donohue B, Chelliah N, et al. Predictors of in-hospital and 6-month outcome after acute myocardial infarction in the reperfusion era: the Primary Angioplasty in Myocardial Infarction (PAMI) trail. J Am Coll Cardiol. 1995 Feb;25(2):370-7. doi: 10.1016/0735-1097(94)00367-y.</citation>
    <PMID>7829790</PMID>
  </reference>
  <reference>
    <citation>Zijlstra F, de Boer MJ, Hoorntje JC, Reiffers S, Reiber JH, Suryapranata H. A comparison of immediate coronary angioplasty with intravenous streptokinase in acute myocardial infarction. N Engl J Med. 1993 Mar 11;328(10):680-4. doi: 10.1056/NEJM199303113281002.</citation>
    <PMID>8433726</PMID>
  </reference>
  <reference>
    <citation>Mintz GS. Remodeling and Restenosis: Observations from Serial Intravascular Ultrasound Studies. Curr Interv Cardiol Rep. 2000 Nov;2(4):316-325.</citation>
    <PMID>11096682</PMID>
  </reference>
  <reference>
    <citation>Zhu MM, Feit A, Chadow H, Alam M, Kwan T, Clark LT. Primary stent implantation compared with primary balloon angioplasty for acute myocardial infarction: a meta-analysis of randomized clinical trials. Am J Cardiol. 2001 Aug 1;88(3):297-301. doi: 10.1016/s0002-9149(01)01645-9. No abstract available.</citation>
    <PMID>11472712</PMID>
  </reference>
  <reference>
    <citation>De Luca G, Suryapranata H, Stone GW, Antoniucci D, Biondi-Zoccai G, Kastrati A, Chiariello M, Marino P. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. Int J Cardiol. 2008 May 7;126(1):37-44. doi: 10.1016/j.ijcard.2007.03.112. Epub 2007 Jun 4.</citation>
    <PMID>17544528</PMID>
  </reference>
  <reference>
    <citation>Suryapranata H, De Luca G, van 't Hof AW, Ottervanger JP, Hoorntje JC, Dambrink JH, Gosselink AT, Zijlstra F, de Boer MJ. Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomised comparison in a large cohort of unselected patients. Heart. 2005 May;91(5):641-5. doi: 10.1136/hrt.2004.056705.</citation>
    <PMID>15831652</PMID>
  </reference>
  <reference>
    <citation>Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006 Sep 14;355(11):1105-13. doi: 10.1056/NEJMoa062598.</citation>
    <PMID>16971717</PMID>
  </reference>
  <reference>
    <citation>Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvanne M, Suttorp MJ, Violini R, Schomig A. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007 Nov;28(22):2706-13. doi: 10.1093/eurheartj/ehm402. Epub 2007 Sep 27.</citation>
    <PMID>17901079</PMID>
  </reference>
  <reference>
    <citation>De Luca G, Stone GW, Suryapranata H, Laarman GJ, Menichelli M, Kaiser C, Valgimigli M, Di Lorenzo E, Dirksen MT, Spaulding C, Pittl U, Violini R, Percoco G, Marino P. Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. Int J Cardiol. 2009 Apr 3;133(2):213-22. doi: 10.1016/j.ijcard.2007.12.040. Epub 2008 Apr 3.</citation>
    <PMID>18394731</PMID>
  </reference>
  <reference>
    <citation>Degertekin M, Serruys PW, Tanabe K, Lee CH, Sousa JE, Colombo A, Morice MC, Ligthart JM, de Feyter PJ. Long-term follow-up of incomplete stent apposition in patients who received sirolimus-eluting stent for de novo coronary lesions: an intravascular ultrasound analysis. Circulation. 2003 Dec 2;108(22):2747-50. doi: 10.1161/01.CIR.0000103666.25660.77. Epub 2003 Nov 24.</citation>
    <PMID>14638542</PMID>
  </reference>
  <reference>
    <citation>McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.</citation>
    <PMID>15500897</PMID>
  </reference>
  <reference>
    <citation>Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008 Sep 9;118(11):1138-45. doi: 10.1161/CIRCULATIONAHA.107.762047. Epub 2008 Aug 25.</citation>
    <PMID>18725485</PMID>
  </reference>
  <reference>
    <citation>Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ. 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. JACC Cardiovasc Interv. 2011 Jan;4(1):24-9. doi: 10.1016/j.jcin.2010.11.003.</citation>
    <PMID>21251625</PMID>
  </reference>
  <reference>
    <citation>Hong MK, Mintz GS, Lee CW, Kim YH, Lee SW, Song JM, Han KH, Kang DH, Song JK, Kim JJ, Park SW, Park SJ. Incidence, mechanism, predictors, and long-term prognosis of late stent malapposition after bare-metal stent implantation. Circulation. 2004 Feb 24;109(7):881-6. doi: 10.1161/01.CIR.0000116751.88818.10. Epub 2004 Feb 16.</citation>
    <PMID>14967732</PMID>
  </reference>
  <reference>
    <citation>Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009 May;2(5):445-52. doi: 10.1016/j.jcin.2009.01.012.</citation>
    <PMID>19463469</PMID>
  </reference>
  <reference>
    <citation>Herdeg C, Oberhoff M, Baumbach A, Blattner A, Axel DI, Schroder S, Heinle H, Karsch KR. Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo. J Am Coll Cardiol. 2000 Jun;35(7):1969-76. doi: 10.1016/s0735-1097(00)00614-8.</citation>
    <PMID>10841250</PMID>
  </reference>
  <reference>
    <citation>Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.</citation>
    <PMID>17101615</PMID>
  </reference>
  <reference>
    <citation>Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2008 Oct;97(10):773-81. doi: 10.1007/s00392-008-0682-5. Epub 2008 Jun 5.</citation>
    <PMID>18536865</PMID>
  </reference>
  <reference>
    <citation>Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.</citation>
    <PMID>19487593</PMID>
  </reference>
  <reference>
    <citation>De Labriolle A, Pakala R, Bonello L, Lemesle G, Scheinowitz M, Waksman R. Paclitaxel-eluting balloon: from bench to bed. Catheter Cardiovasc Interv. 2009 Apr 1;73(5):643-52. doi: 10.1002/ccd.21895.</citation>
    <PMID>19309715</PMID>
  </reference>
  <reference>
    <citation>Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010 Mar;99(3):165-74. doi: 10.1007/s00392-009-0101-6. Epub 2010 Jan 6.</citation>
    <PMID>20052480</PMID>
  </reference>
  <reference>
    <citation>Vos NS, Dirksen MT, Vink MA, van Nooijen FC, Amoroso G, Herrman JP, Kiemeneij F, Patterson MS, Slagboom T, van der Schaaf RJ. Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study. EuroIntervention. 2014 Sep;10(5):584-90. doi: 10.4244/EIJV10I5A101.</citation>
    <PMID>25256200</PMID>
  </reference>
  <reference>
    <citation>De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.</citation>
    <PMID>8124786</PMID>
  </reference>
  <reference>
    <citation>Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.</citation>
    <PMID>8637515</PMID>
  </reference>
  <reference>
    <citation>De Bruyne B, Pijls NH, Bartunek J, Kulecki K, Bech JW, De Winter H, Van Crombrugge P, Heyndrickx GR, Wijns W. Fractional flow reserve in patients with prior myocardial infarction. Circulation. 2001 Jul 10;104(2):157-62. doi: 10.1161/01.cir.104.2.157.</citation>
    <PMID>11447079</PMID>
  </reference>
  <reference>
    <citation>Bech GJ, De Bruyne B, Pijls NH, de Muinck ED, Hoorntje JC, Escaned J, Stella PR, Boersma E, Bartunek J, Koolen JJ, Wijns W. Fractional flow reserve to determine the appropriateness of angioplasty in moderate coronary stenosis: a randomized trial. Circulation. 2001 Jun 19;103(24):2928-34. doi: 10.1161/01.cir.103.24.2928.</citation>
    <PMID>11413082</PMID>
  </reference>
  <reference>
    <citation>Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.</citation>
    <PMID>19144937</PMID>
  </reference>
  <reference>
    <citation>De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27. Erratum In: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Mobius-Winkler, Sven].</citation>
    <PMID>22924638</PMID>
  </reference>
  <reference>
    <citation>Legrand V, Mancini GB, Bates ER, Hodgson JM, Gross MD, Vogel RA. Comparative study of coronary flow reserve, coronary anatomy and results of radionuclide exercise tests in patients with coronary artery disease. J Am Coll Cardiol. 1986 Nov;8(5):1022-32. doi: 10.1016/s0735-1097(86)80377-1.</citation>
    <PMID>3760377</PMID>
  </reference>
  <reference>
    <citation>Zijlstra F, Fioretti P, Reiber JH, Serruys PW. Which cineangiographically assessed anatomic variable correlates best with functional measurements of stenosis severity? A comparison of quantitative analysis of the coronary cineangiogram with measured coronary flow reserve and exercise/redistribution thallium-201 scintigraphy. J Am Coll Cardiol. 1988 Sep;12(3):686-91. doi: 10.1016/s0735-1097(88)80057-3.</citation>
    <PMID>3403826</PMID>
  </reference>
  <reference>
    <citation>Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010 Jun 22;55(25):2816-21. doi: 10.1016/j.jacc.2009.11.096.</citation>
    <PMID>20579537</PMID>
  </reference>
  <reference>
    <citation>Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.</citation>
    <PMID>21481828</PMID>
  </reference>
  <reference>
    <citation>Klauss V, Erdin P, Rieber J, Leibig M, Stempfle HU, Konig A, Baylacher M, Theisen K, Haufe MC, Sroczynski G, Schiele T, Siebert U. Fractional flow reserve for the prediction of cardiac events after coronary stent implantation: results of a multivariate analysis. Heart. 2005 Feb;91(2):203-6. doi: 10.1136/hrt.2003.027797.</citation>
    <PMID>15657233</PMID>
  </reference>
  <reference>
    <citation>Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.</citation>
    <PMID>22154731</PMID>
  </reference>
  <reference>
    <citation>Jeremias A, Maehara A, Genereux P, Asrress KN, Berry C, De Bruyne B, Davies JE, Escaned J, Fearon WF, Gould KL, Johnson NP, Kirtane AJ, Koo BK, Marques KM, Nijjer S, Oldroyd KG, Petraco R, Piek JJ, Pijls NH, Redwood S, Siebes M, Spaan JAE, van 't Veer M, Mintz GS, Stone GW. Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve: the RESOLVE study. J Am Coll Cardiol. 2014 Apr 8;63(13):1253-1261. doi: 10.1016/j.jacc.2013.09.060. Epub 2013 Nov 6.</citation>
    <PMID>24211503</PMID>
  </reference>
  <reference>
    <citation>Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1149-59. doi: 10.1016/S0140-6736(09)61484-7. Epub 2009 Aug 28.</citation>
    <PMID>19717185</PMID>
  </reference>
  <reference>
    <citation>Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005.</citation>
    <PMID>19801025</PMID>
  </reference>
  <reference>
    <citation>Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.</citation>
    <PMID>22922416</PMID>
  </reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>June 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Onze Lieve Vrouwe Gasthuis</investigator_affiliation>
    <investigator_full_name>J.P.R. Herrman</investigator_full_name>
    <investigator_title>J.P.R.Herrman, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Coronary artery disease</keyword>
  <keyword>Acute myocardial infarction</keyword>
  <keyword>Drug-coated balloon</keyword>
  <keyword>Drug-eluting stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02219802
org study id: NL48495.100.14
nct id: NCT02219802
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and
      drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in
      primary percutaneous coronary intervention (PPCI). However, this did not result in a
      reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of
      the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility
      of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term
      clinical results, with sustained safety and efficacy at 12 months follow-up. To date little
      is known about the long-term effects of this treatment modality in STEMI. Besides,
      angiographic follow-up is of great clinical importance by giving insight on the treated
      infarct lesion and to assess the functional angioplasty result.

      Objective: This randomized controlled, non-inferiority trial is mainly designed to
      prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only
      strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction
      (STEMI).
Rationale: Compared with balloon angioplasty, implantation of bare metal stents (BMS) and
      drug eluting stents (DES) have shown to reduce repeat target lesion revascularization in
      primary percutaneous coronary intervention (PPCI). However, this did not result in a
      reduction of mortality or recurrent myocardial infarction. Furthermore, there are concerns of
      the occurrence of stent thrombosis. The PAPPA-pilot study, evaluating safety and feasibility
      of using a drug-coated balloon (DCB) only strategy in PPCI, showed good short- and long-term
      clinical results, with sustained safety and efficacy at 12 months follow-up. To date little
      is known about the long-term effects of this treatment modality in STEMI. Besides,
      angiographic follow-up is of great clinical importance by giving insight on the treated
      infarct lesion and to assess the functional angioplasty result.

      Objective: This randomized controlled, non-inferiority trial is mainly designed to
      prospectively assess the safety and efficacy of a CE-marked paclitaxel-eluting balloon only
      strategy vs. third generation DES in the setting of a ST-elevation myocardial infarction
      (STEMI).

      Study design: This is a prospective, single center, non-inferiority, randomized controlled
      trial.

      Study population: All patients presenting with STEMI and suitable for PPCI.

      Intervention: PPCI will be performed according to current guidelines. After thrombus
      aspiration and pre-dilatation, randomization between a DCB only strategy (with bail-out
      stenting if indicated) and DES will be done by 1:1 ratio. Concomitant medication will be
      administered according current standards. Control coronary angiography, including measurement
      of the fractional flow reserve (FFR) of the treated lesion(s), will be performed after 9
      months.

      Main study parameters/endpoints: The main study parameter is the fractional flow reserve at 9
      months follow-up. Secondary study parameters include cardiac death, recurrent myocardial
      infarction in the target vessel area and ischemia driven target lesion revascularisation at 9
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fractional flow reserve (FFR)
time frame: At 9 months follow-up
description: Fractional flow reserve is the ratio of mean coronary pressure distal of the treated lesion to mean aortic pressure during maximum hyperemia.
measure: Major adverse cardiac event (MACE)
time frame: In-hospital, at 1 and 9 months follow-up and at 2, 3, 4 and 5 year follow-up.
description: Cardiac death (ARC); defined as any death in which a cardiac cause cannot be excluded.
Recurrent MI in the target vessel area.
Ischemia driven target lesion revascularization (PCI within 5 mm of the treated segment in case of balloon, or stent area borders in case of stent, or CABG of the target vessel).
measure: Angiographic endpoint: iFR
time frame: At 9 months follow-up.
measure: ST-segment resolution
time frame: 90 minutes after initial procedure
description: ST-segment resolution post-initial procedure at 90 minutes, defined as the ST-segment deviation resolution in only the single lead showing maximum deviation.
measure: Non-coronary artery bypass grafting major bleeding
time frame: At 1 month follow-up
description: Intracranial, intraocular, intra-articular or retroperitoneal bleeding
Access site bleed requiring intervention/surgery
Hematoma ≥ 5 cm
Hemoglobin (Hgb) ≥4 g/dL without an overt source
Hgb ≥3 g/dL with an overt source
Operation for bleeding
Any blood transfusions
measure: Stent thrombosis
time frame: During follow-up
description: Definite or confirmed stent thrombosis: Angiographic confirmation of vessel occlusion or thrombus formation within, or adjacent to, the stented segment or proven stent thrombosis at autopsy.
Probable stent thrombosis: Unexplained death within 30 days or target vessel recurrent MI without angiographic confirmation.
Possible stent thrombosis: Unexplained death after 30 days.
measure: Angiographic endpoint: TIMI flow
time frame: At 9 months follow-up
measure: Angiographic endpoint: late lumen loss
time frame: At 9 months follow-up
measure: Angiographic endpoint: minimal lumen diameter
time frame: At 9 months follow-up
measure: Angiographic endpoint: diameter stenosis
time frame: At 9 months follow-up
arm group label: Drug-eluting stent
arm group type: Active Comparator
description: Treatment of infarct related laesion with a drug-eluting stent
arm group label: Drug-coated balloon
arm group type: Experimental
description: After treatment of the infarct related artery with a drug-coated ballon, an additional BMS is advised to be used in case of residual stenosis > 50% or coronary artery dissection type > B.
intervention type: Procedure
intervention name: Treatment according arm
arm group label: Drug-coated balloon
arm group label: Drug-eluting stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: R. J. van der Schaaf, MD, PhD
role: Principal Investigator
affiliation: OLVG
last name: R. J. van der Schaaf, MD, PhD
phone: +31-20-5992387
email: r.j.vanderschaaf@olvg.nl
last name: N. S. Vos, MD
phone: +13-20-5992387
email: n.s.vos@olvg.nl
facility: 
investigator: 
country: Netherlands
citation: Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
PMID: 12517460
citation: Zijlstra F, Hoorntje JC, de Boer MJ, Reiffers S, Miedema K, Ottervanger JP, van 't Hof AW, Suryapranata H. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med. 1999 Nov 4;341(19):1413-9. doi: 10.1056/NEJM199911043411901.
PMID: 10547403
citation: Stone GW, Grines CL, Browne KF, Marco J, Rothbaum D, O'Keefe J, Hartzler GO, Overlie P, Donohue B, Chelliah N, et al. Predictors of in-hospital and 6-month outcome after acute myocardial infarction in the reperfusion era: the Primary Angioplasty in Myocardial Infarction (PAMI) trail. J Am Coll Cardiol. 1995 Feb;25(2):370-7. doi: 10.1016/0735-1097(94)00367-y.
PMID: 7829790
citation: Zijlstra F, de Boer MJ, Hoorntje JC, Reiffers S, Reiber JH, Suryapranata H. A comparison of immediate coronary angioplasty with intravenous streptokinase in acute myocardial infarction. N Engl J Med. 1993 Mar 11;328(10):680-4. doi: 10.1056/NEJM199303113281002.
PMID: 8433726
citation: Mintz GS. Remodeling and Restenosis: Observations from Serial Intravascular Ultrasound Studies. Curr Interv Cardiol Rep. 2000 Nov;2(4):316-325.
PMID: 11096682
citation: Zhu MM, Feit A, Chadow H, Alam M, Kwan T, Clark LT. Primary stent implantation compared with primary balloon angioplasty for acute myocardial infarction: a meta-analysis of randomized clinical trials. Am J Cardiol. 2001 Aug 1;88(3):297-301. doi: 10.1016/s0002-9149(01)01645-9. No abstract available.
PMID: 11472712
citation: De Luca G, Suryapranata H, Stone GW, Antoniucci D, Biondi-Zoccai G, Kastrati A, Chiariello M, Marino P. Coronary stenting versus balloon angioplasty for acute myocardial infarction: a meta-regression analysis of randomized trials. Int J Cardiol. 2008 May 7;126(1):37-44. doi: 10.1016/j.ijcard.2007.03.112. Epub 2007 Jun 4.
PMID: 17544528
citation: Suryapranata H, De Luca G, van 't Hof AW, Ottervanger JP, Hoorntje JC, Dambrink JH, Gosselink AT, Zijlstra F, de Boer MJ. Is routine stenting for acute myocardial infarction superior to balloon angioplasty? A randomised comparison in a large cohort of unselected patients. Heart. 2005 May;91(5):641-5. doi: 10.1136/hrt.2004.056705.
PMID: 15831652
citation: Laarman GJ, Suttorp MJ, Dirksen MT, van Heerebeek L, Kiemeneij F, Slagboom T, van der Wieken LR, Tijssen JG, Rensing BJ, Patterson M. Paclitaxel-eluting versus uncoated stents in primary percutaneous coronary intervention. N Engl J Med. 2006 Sep 14;355(11):1105-13. doi: 10.1056/NEJMoa062598.
PMID: 16971717
citation: Kastrati A, Dibra A, Spaulding C, Laarman GJ, Menichelli M, Valgimigli M, Di Lorenzo E, Kaiser C, Tierala I, Mehilli J, Seyfarth M, Varenne O, Dirksen MT, Percoco G, Varricchio A, Pittl U, Syvanne M, Suttorp MJ, Violini R, Schomig A. Meta-analysis of randomized trials on drug-eluting stents vs. bare-metal stents in patients with acute myocardial infarction. Eur Heart J. 2007 Nov;28(22):2706-13. doi: 10.1093/eurheartj/ehm402. Epub 2007 Sep 27.
PMID: 17901079
citation: De Luca G, Stone GW, Suryapranata H, Laarman GJ, Menichelli M, Kaiser C, Valgimigli M, Di Lorenzo E, Dirksen MT, Spaulding C, Pittl U, Violini R, Percoco G, Marino P. Efficacy and safety of drug-eluting stents in ST-segment elevation myocardial infarction: a meta-analysis of randomized trials. Int J Cardiol. 2009 Apr 3;133(2):213-22. doi: 10.1016/j.ijcard.2007.12.040. Epub 2008 Apr 3.
PMID: 18394731
citation: Degertekin M, Serruys PW, Tanabe K, Lee CH, Sousa JE, Colombo A, Morice MC, Ligthart JM, de Feyter PJ. Long-term follow-up of incomplete stent apposition in patients who received sirolimus-eluting stent for de novo coronary lesions: an intravascular ultrasound analysis. Circulation. 2003 Dec 2;108(22):2747-50. doi: 10.1161/01.CIR.0000103666.25660.77. Epub 2003 Nov 24.
PMID: 14638542
citation: McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.
PMID: 15500897
citation: Nakazawa G, Finn AV, Joner M, Ladich E, Kutys R, Mont EK, Gold HK, Burke AP, Kolodgie FD, Virmani R. Delayed arterial healing and increased late stent thrombosis at culprit sites after drug-eluting stent placement for acute myocardial infarction patients: an autopsy study. Circulation. 2008 Sep 9;118(11):1138-45. doi: 10.1161/CIRCULATIONAHA.107.762047. Epub 2008 Aug 25.
PMID: 18725485
citation: Vink MA, Dirksen MT, Suttorp MJ, Tijssen JG, van Etten J, Patterson MS, Slagboom T, Kiemeneij F, Laarman GJ. 5-year follow-up after primary percutaneous coronary intervention with a paclitaxel-eluting stent versus a bare-metal stent in acute ST-segment elevation myocardial infarction: a follow-up study of the PASSION (Paclitaxel-Eluting Versus Conventional Stent in Myocardial Infarction with ST-Segment Elevation) trial. JACC Cardiovasc Interv. 2011 Jan;4(1):24-9. doi: 10.1016/j.jcin.2010.11.003.
PMID: 21251625
citation: Hong MK, Mintz GS, Lee CW, Kim YH, Lee SW, Song JM, Han KH, Kang DH, Song JK, Kim JJ, Park SW, Park SJ. Incidence, mechanism, predictors, and long-term prognosis of late stent malapposition after bare-metal stent implantation. Circulation. 2004 Feb 24;109(7):881-6. doi: 10.1161/01.CIR.0000116751.88818.10. Epub 2004 Feb 16.
PMID: 14967732
citation: Gonzalo N, Barlis P, Serruys PW, Garcia-Garcia HM, Onuma Y, Ligthart J, Regar E. Incomplete stent apposition and delayed tissue coverage are more frequent in drug-eluting stents implanted during primary percutaneous coronary intervention for ST-segment elevation myocardial infarction than in drug-eluting stents implanted for stable/unstable angina: insights from optical coherence tomography. JACC Cardiovasc Interv. 2009 May;2(5):445-52. doi: 10.1016/j.jcin.2009.01.012.
PMID: 19463469
citation: Herdeg C, Oberhoff M, Baumbach A, Blattner A, Axel DI, Schroder S, Heinle H, Karsch KR. Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo. J Am Coll Cardiol. 2000 Jun;35(7):1969-76. doi: 10.1016/s0735-1097(00)00614-8.
PMID: 10841250
citation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.
PMID: 17101615
citation: Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2008 Oct;97(10):773-81. doi: 10.1007/s00392-008-0682-5. Epub 2008 Jun 5.
PMID: 18536865
citation: Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, Werner GS, Antoni D, Kleber FX, Bocksch W, Leschke M, Ackermann H, Boxberger M, Speck U, Degenhardt R, Scheller B. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009 Jun 16;119(23):2986-94. doi: 10.1161/CIRCULATIONAHA.108.839282. Epub 2009 Jun 1.
PMID: 19487593
citation: De Labriolle A, Pakala R, Bonello L, Lemesle G, Scheinowitz M, Waksman R. Paclitaxel-eluting balloon: from bench to bed. Catheter Cardiovasc Interv. 2009 Apr 1;73(5):643-52. doi: 10.1002/ccd.21895.
PMID: 19309715
citation: Unverdorben M, Kleber FX, Heuer H, Figulla HR, Vallbracht C, Leschke M, Cremers B, Hardt S, Buerke M, Ackermann H, Boxberger M, Degenhardt R, Scheller B. Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. Clin Res Cardiol. 2010 Mar;99(3):165-74. doi: 10.1007/s00392-009-0101-6. Epub 2010 Jan 6.
PMID: 20052480
citation: Vos NS, Dirksen MT, Vink MA, van Nooijen FC, Amoroso G, Herrman JP, Kiemeneij F, Patterson MS, Slagboom T, van der Schaaf RJ. Safety and feasibility of a PAclitaxel-eluting balloon angioplasty in Primary Percutaneous coronary intervention in Amsterdam (PAPPA): one-year clinical outcome of a pilot study. EuroIntervention. 2014 Sep;10(5):584-90. doi: 10.4244/EIJV10I5A101.
PMID: 25256200
citation: De Bruyne B, Baudhuin T, Melin JA, Pijls NH, Sys SU, Bol A, Paulus WJ, Heyndrickx GR, Wijns W. Coronary flow reserve calculated from pressure measurements in humans. Validation with positron emission tomography. Circulation. 1994 Mar;89(3):1013-22. doi: 10.1161/01.cir.89.3.1013.
PMID: 8124786
citation: Pijls NH, De Bruyne B, Peels K, Van Der Voort PH, Bonnier HJ, Bartunek J Koolen JJ, Koolen JJ. Measurement of fractional flow reserve to assess the functional severity of coronary-artery stenoses. N Engl J Med. 1996 Jun 27;334(26):1703-8. doi: 10.1056/NEJM199606273342604.
PMID: 8637515
citation: De Bruyne B, Pijls NH, Bartunek J, Kulecki K, Bech JW, De Winter H, Van Crombrugge P, Heyndrickx GR, Wijns W. Fractional flow reserve in patients with prior myocardial infarction. Circulation. 2001 Jul 10;104(2):157-62. doi: 10.1161/01.cir.104.2.157.
PMID: 11447079
citation: Bech GJ, De Bruyne B, Pijls NH, de Muinck ED, Hoorntje JC, Escaned J, Stella PR, Boersma E, Bartunek J, Koolen JJ, Wijns W. Fractional flow reserve to determine the appropriateness of angioplasty in moderate coronary stenosis: a randomized trial. Circulation. 2001 Jun 19;103(24):2928-34. doi: 10.1161/01.cir.103.24.2928.
PMID: 11413082
citation: Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611.
PMID: 19144937
citation: De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27. Erratum In: N Engl J Med. 2012 Nov;367(18):1768. Mobius-Winckler, Sven [corrected to Mobius-Winkler, Sven].
PMID: 22924638
citation: Legrand V, Mancini GB, Bates ER, Hodgson JM, Gross MD, Vogel RA. Comparative study of coronary flow reserve, coronary anatomy and results of radionuclide exercise tests in patients with coronary artery disease. J Am Coll Cardiol. 1986 Nov;8(5):1022-32. doi: 10.1016/s0735-1097(86)80377-1.
PMID: 3760377
citation: Zijlstra F, Fioretti P, Reiber JH, Serruys PW. Which cineangiographically assessed anatomic variable correlates best with functional measurements of stenosis severity? A comparison of quantitative analysis of the coronary cineangiogram with measured coronary flow reserve and exercise/redistribution thallium-201 scintigraphy. J Am Coll Cardiol. 1988 Sep;12(3):686-91. doi: 10.1016/s0735-1097(88)80057-3.
PMID: 3403826
citation: Tonino PA, Fearon WF, De Bruyne B, Oldroyd KG, Leesar MA, Ver Lee PN, Maccarthy PA, Van't Veer M, Pijls NH. Angiographic versus functional severity of coronary artery stenoses in the FAME study fractional flow reserve versus angiography in multivessel evaluation. J Am Coll Cardiol. 2010 Jun 22;55(25):2816-21. doi: 10.1016/j.jacc.2009.11.096.
PMID: 20579537
citation: Nam CW, Hur SH, Cho YK, Park HS, Yoon HJ, Kim H, Chung IS, Kim YN, Kim KB, Doh JH, Koo BK, Tahk SJ, Fearon WF. Relation of fractional flow reserve after drug-eluting stent implantation to one-year outcomes. Am J Cardiol. 2011 Jun 15;107(12):1763-7. doi: 10.1016/j.amjcard.2011.02.329. Epub 2011 Apr 8.
PMID: 21481828
citation: Klauss V, Erdin P, Rieber J, Leibig M, Stempfle HU, Konig A, Baylacher M, Theisen K, Haufe MC, Sroczynski G, Schiele T, Siebert U. Fractional flow reserve for the prediction of cardiac events after coronary stent implantation: results of a multivariate analysis. Heart. 2005 Feb;91(2):203-6. doi: 10.1136/hrt.2003.027797.
PMID: 15657233
citation: Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7.
PMID: 22154731
citation: Jeremias A, Maehara A, Genereux P, Asrress KN, Berry C, De Bruyne B, Davies JE, Escaned J, Fearon WF, Gould KL, Johnson NP, Kirtane AJ, Koo BK, Marques KM, Nijjer S, Oldroyd KG, Petraco R, Piek JJ, Pijls NH, Redwood S, Siebes M, Spaan JAE, van 't Veer M, Mintz GS, Stone GW. Multicenter core laboratory comparison of the instantaneous wave-free ratio and resting Pd/Pa with fractional flow reserve: the RESOLVE study. J Am Coll Cardiol. 2014 Apr 8;63(13):1253-1261. doi: 10.1016/j.jacc.2013.09.060. Epub 2013 Nov 6.
PMID: 24211503
citation: Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1149-59. doi: 10.1016/S0140-6736(09)61484-7. Epub 2009 Aug 28.
PMID: 19717185
citation: Cortese B, Picchi A, Micheli A, Ebert AG, Parri F, Severi S, Limbruno U. Comparison of prolonged bivalirudin infusion versus intraprocedural in preventing myocardial damage after percutaneous coronary intervention in patients with angina pectoris. Am J Cardiol. 2009 Oct 15;104(8):1063-8. doi: 10.1016/j.amjcard.2009.06.005.
PMID: 19801025
citation: Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC); Steg PG, James SK, Atar D, Badano LP, Blomstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, van 't Hof A, Widimsky P, Zahger D. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012 Oct;33(20):2569-619. doi: 10.1093/eurheartj/ehs215. Epub 2012 Aug 24. No abstract available.
PMID: 22922416
responsible party type: Principal Investigator
investigator affiliation: Onze Lieve Vrouwe Gasthuis
investigator full name: J.P.R. Herrman
investigator title: J.P.R.Herrman, MD, PhD
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Myocardial Infarction
mesh term: Infarction