<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/NCT03026465</url>
  </required_header>
  <id_info>
    <org_study_id>VISTA</org_study_id>
    <nct_id>NCT03026465</nct_id>
  </id_info>
  <brief_title>Vessel Injury in Relation With Strut Thickness Assessed by OCT</brief_title>
  <acronym>VISTA</acronym>
  <official_title>Vessel Injury in Relation With Strut Thickness Assessed by OCT (VISTA): A Comparison of Vascular Injury Induced by a Polymer Free Sirolimus and Probucol Eluting Stent and a Biodegradable-polymer Biolimus-eluting Stent</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundacion Investigacion Interhospitalaria Cardiovascular</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>B.Braun Surgical SA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundacion Investigacion Interhospitalaria Cardiovascular</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the present study is to determine the relation between vascular injury&#xD;
      induced by the stent and strut thickness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thinner struts produce less arterial injury after stent implantation.The objective of the&#xD;
      present study is to determine the relation between vascular injury induced by the stent and&#xD;
      strut thickness. Vessel injury after stent implantation will be evaluated with optical&#xD;
      coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex&#xD;
      ISAR 50 microns and Biomatrix 120 microns) will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 16, 2017</start_date>
  <completion_date type="Actual">July 27, 2018</completion_date>
  <primary_completion_date type="Actual">July 27, 2018</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>OCT-based intimal injury score</measure>
    <time_frame>Up to 1 day (evaluated after stent implantation)</time_frame>
    <description>OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tissue prolapse area</measure>
    <time_frame>Up to 1 day (evaluated after stent implantation)</time_frame>
    <description>Tissue prolapse area assessed by OCT after implantation of Coroflex-ISAR and Biomatrix will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of stent malapposition</measure>
    <time_frame>Up to 1 day (evaluated after stent implantation)</time_frame>
    <description>Stent apposition after implantation of Coroflex-ISAR and Biomatrix as assessed by OCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of stent underexpansion</measure>
    <time_frame>Up to 1 day (evaluated after stent implantation)</time_frame>
    <description>Stent expansion will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent symmetry after implantation</measure>
    <time_frame>Up to 1 day (evaluated after stent implantation)</time_frame>
    <description>Stent symmetry will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline plaque type</measure>
    <time_frame>Up to 1 day (evaluated after stent implantation)</time_frame>
    <description>Baseline plaque type will be assessed by OCT (fibrous, fibrocalcific or lipid-rich)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Coroflex ISAR stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PCI with a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR stent) with very thin struts (50 µm). During the PCI, an OCT assessment (baseline and post-implantation) will be performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biomatrix stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PCI with a biodegradable-polymer biolimus-eluting stent (Biomatrix stent) with 120 µm struts. During the PCI, an OCT assessment (baseline and post-implantation) will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polymer-free stent</intervention_name>
    <description>PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)</description>
    <arm_group_label>Coroflex ISAR stent</arm_group_label>
    <other_name>Coroflex ISAR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biodegradable-polymer stent</intervention_name>
    <description>PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)</description>
    <arm_group_label>Biomatrix stent</arm_group_label>
    <other_name>Biomatrix</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years&#xD;
&#xD;
          -  Ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the&#xD;
             presence of &gt;50% de novo stenosis located in native coronary vessels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Target lesion located in the left main stem&#xD;
&#xD;
          -  STEMI&#xD;
&#xD;
          -  Restenosis&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Malignancies or other comorbid conditions with life expectancy less than 12 months or&#xD;
             that may result in protocol noncompliance&#xD;
&#xD;
          -  Known allergy to the study medications (probucol, sirolimus, zotarolimus)&#xD;
&#xD;
          -  Pregnancy (present, suspected, or planned)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nieves Gonzalo, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Clinico San Carlos de Madrid</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Vigo</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Princesa</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Sullivan TM, Ainsworth SD, Langan EM, Taylor S, Snyder B, Cull D, Youkey J, Laberge M. Effect of endovascular stent strut geometry on vascular injury, myointimal hyperplasia, and restenosis. J Vasc Surg. 2002 Jul;36(1):143-9. doi: 10.1067/mva.2002.122878.</citation>
    <PMID>12096272</PMID>
  </reference>
  <reference>
    <citation>Hara H, Nakamura M, Palmaz JC, Schwartz RS. Role of stent design and coatings on restenosis and thrombosis. Adv Drug Deliv Rev. 2006 Jun 3;58(3):377-86. doi: 10.1016/j.addr.2006.01.022. Epub 2006 Mar 6.</citation>
    <PMID>16650911</PMID>
  </reference>
  <reference>
    <citation>Farb A, Weber DK, Kolodgie FD, Burke AP, Virmani R. Morphological predictors of restenosis after coronary stenting in humans. Circulation. 2002 Jun 25;105(25):2974-80. doi: 10.1161/01.cir.0000019071.72887.bd.</citation>
    <PMID>12081990</PMID>
  </reference>
  <reference>
    <citation>Rogers C, Edelman ER. Endovascular stent design dictates experimental restenosis and thrombosis. Circulation. 1995 Jun 15;91(12):2995-3001. doi: 10.1161/01.cir.91.12.2995.</citation>
    <PMID>7796511</PMID>
  </reference>
  <reference>
    <citation>Scott NA. Restenosis following implantation of bare metal coronary stents: pathophysiology and pathways involved in the vascular response to injury. Adv Drug Deliv Rev. 2006 Jun 3;58(3):358-76. doi: 10.1016/j.addr.2006.01.015. Epub 2006 Mar 6.</citation>
    <PMID>16733073</PMID>
  </reference>
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    <citation>Foin N, Lee RD, Torii R, Guitierrez-Chico JL, Mattesini A, Nijjer S, Sen S, Petraco R, Davies JE, Di Mario C, Joner M, Virmani R, Wong P. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol. 2014 Dec 20;177(3):800-8. doi: 10.1016/j.ijcard.2014.09.143. Epub 2014 Oct 7.</citation>
    <PMID>25449502</PMID>
  </reference>
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    <citation>Kolandaivelu K, Swaminathan R, Gibson WJ, Kolachalama VB, Nguyen-Ehrenreich KL, Giddings VL, Coleman L, Wong GK, Edelman ER. Stent thrombogenicity early in high-risk interventional settings is driven by stent design and deployment and protected by polymer-drug coatings. Circulation. 2011 Apr 5;123(13):1400-9. doi: 10.1161/CIRCULATIONAHA.110.003210. Epub 2011 Mar 21.</citation>
    <PMID>21422389</PMID>
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    <citation>Foin N, Gutierrez-Chico JL, Nakatani S, Torii R, Bourantas CV, Sen S, Nijjer S, Petraco R, Kousera C, Ghione M, Onuma Y, Garcia-Garcia HM, Francis DP, Wong P, Di Mario C, Davies JE, Serruys PW. Incomplete stent apposition causes high shear flow disturbances and delay in neointimal coverage as a function of strut to wall detachment distance: implications for the management of incomplete stent apposition. Circ Cardiovasc Interv. 2014 Apr;7(2):180-9. doi: 10.1161/CIRCINTERVENTIONS.113.000931. Epub 2014 Mar 18.</citation>
    <PMID>24642998</PMID>
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    <citation>Bourantas CV, Papafaklis MI, Kotsia A, Farooq V, Muramatsu T, Gomez-Lara J, Zhang YJ, Iqbal J, Kalatzis FG, Naka KK, Fotiadis DI, Dorange C, Wang J, Rapoza R, Garcia-Garcia HM, Onuma Y, Michalis LK, Serruys PW. Effect of the endothelial shear stress patterns on neointimal proliferation following drug-eluting bioresorbable vascular scaffold implantation: an optical coherence tomography study. JACC Cardiovasc Interv. 2014 Mar;7(3):315-24. doi: 10.1016/j.jcin.2013.05.034. Epub 2014 Feb 13.</citation>
    <PMID>24529931</PMID>
  </reference>
  <reference>
    <citation>Kastrati A, Mehilli J, Dirschinger J, Dotzer F, Schuhlen H, Neumann FJ, Fleckenstein M, Pfafferott C, Seyfarth M, Schomig A. [Intracoronary Stenting and Angiographic Results Strut Thickness Effect on Restenosis Outcome (ISAR-STEREO) Trial]. Vestn Rentgenol Radiol. 2012 Mar-Apr;(2):52-60. Russian.</citation>
    <PMID>22730760</PMID>
  </reference>
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    <citation>Pache J, Kastrati A, Mehilli J, Schuhlen H, Dotzer F, Hausleiter J, Fleckenstein M, Neumann FJ, Sattelberger U, Schmitt C, Muller M, Dirschinger J, Schomig A. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol. 2003 Apr 16;41(8):1283-8. doi: 10.1016/s0735-1097(03)00119-0.</citation>
    <PMID>12706922</PMID>
  </reference>
  <reference>
    <citation>Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006 Jul 4;48(1):193-202. doi: 10.1016/j.jacc.2006.03.042. Epub 2006 May 5.</citation>
    <PMID>16814667</PMID>
  </reference>
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    <citation>Koppara T, Joner M, Bayer G, Steigerwald K, Diener T, Wittchow E. Histopathological comparison of biodegradable polymer and permanent polymer based sirolimus eluting stents in a porcine model of coronary stent implantation. Thromb Haemost. 2012 Jun;107(6):1161-71. doi: 10.1160/TH12-01-0043. Epub 2012 Apr 26.</citation>
    <PMID>22535188</PMID>
  </reference>
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    <citation>Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.</citation>
    <PMID>17438147</PMID>
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    <citation>Joner M, Nakazawa G, Finn AV, Quee SC, Coleman L, Acampado E, Wilson PS, Skorija K, Cheng Q, Xu X, Gold HK, Kolodgie FD, Virmani R. Endothelial cell recovery between comparator polymer-based drug-eluting stents. J Am Coll Cardiol. 2008 Jul 29;52(5):333-42. doi: 10.1016/j.jacc.2008.04.030.</citation>
    <PMID>18652940</PMID>
  </reference>
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    <citation>Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007 Jul;27(7):1500-10. doi: 10.1161/ATVBAHA.107.144220. Epub 2007 May 17.</citation>
    <PMID>17510464</PMID>
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    <citation>Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, Juni P, Schomig A, Windecker S, Kastrati A. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and LEADERS randomized trials. Eur Heart J. 2012 May;33(10):1214-22. doi: 10.1093/eurheartj/ehs086. Epub 2012 Mar 24.</citation>
    <PMID>22447805</PMID>
  </reference>
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    <citation>Smits PC, Hofma S, Togni M, Vazquez N, Valdes M, Voudris V, Slagboom T, Goy JJ, Vuillomenet A, Serra A, Nouche RT, den Heijer P, van der Ent M. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013 Feb 23;381(9867):651-60. doi: 10.1016/S0140-6736(12)61852-2. Epub 2013 Jan 30.</citation>
    <PMID>23374650</PMID>
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    <citation>Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53.</citation>
    <PMID>26196753</PMID>
  </reference>
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    <citation>Otsuka F, Cheng Q, Yahagi K, Acampado E, Sheehy A, Yazdani SK, Sakakura K, Euller K, Perkins LEL, Kolodgie FD, Virmani R, Joner M. Acute Thrombogenicity of a Durable Polymer Everolimus-Eluting Stent Relative to Contemporary Drug-Eluting Stents With Biodegradable Polymer Coatings Assessed Ex Vivo in a Swine Shunt Model. JACC Cardiovasc Interv. 2015 Aug 17;8(9):1248-1260. doi: 10.1016/j.jcin.2015.03.029.</citation>
    <PMID>26292590</PMID>
  </reference>
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    <citation>Otsuka F, Yahagi K, Ladich E, Kutys R, Alexander R, Fowler D, Virmani R, Joner M. Hypersensitivity reaction in the US Food and Drug Administration-approved second-generation drug-eluting stents: histopathological assessment with ex vivo optical coherence tomography. Circulation. 2015 Jan 20;131(3):322-4. doi: 10.1161/CIRCULATIONAHA.114.012658. No abstract available.</citation>
    <PMID>25601953</PMID>
  </reference>
  <reference>
    <citation>Massberg S, Byrne RA, Kastrati A, Schulz S, Pache J, Hausleiter J, Ibrahim T, Fusaro M, Ott I, Schomig A, Laugwitz KL, Mehilli J; Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting Versus Zotarolimus- Eluting Stents (ISAR-TEST 5) Investigators. Polymer-free sirolimus- and probucol-eluting versus new generation zotarolimus-eluting stents in coronary artery disease: the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol-Eluting versus Zotarolimus-eluting Stents (ISAR-TEST 5) trial. Circulation. 2011 Aug 2;124(5):624-32. doi: 10.1161/CIRCULATIONAHA.111.026732. Epub 2011 Jul 18.</citation>
    <PMID>21768546</PMID>
  </reference>
  <reference>
    <citation>Alfonso F, Sandoval J, Perez-Vizcayno MJ, Cardenas A, Gonzalo N, Jimenez-Quevedo P, Ibanez B, Nunez-Gil I, Rivero F, Escaned J, Fernandez-Ortiz A, Macaya C. Mechanisms of balloon angioplasty and repeat stenting in patients with drug-eluting in-stent restenosis. Int J Cardiol. 2015 Jan 15;178:213-20. doi: 10.1016/j.ijcard.2014.10.139. Epub 2014 Oct 23.</citation>
    <PMID>25464257</PMID>
  </reference>
  <reference>
    <citation>Gonzalo N, Serruys PW, Okamura T, Shen ZJ, Onuma Y, Garcia-Garcia HM, Sarno G, Schultz C, van Geuns RJ, Ligthart J, Regar E. Optical coherence tomography assessment of the acute effects of stent implantation on the vessel wall: a systematic quantitative approach. Heart. 2009 Dec;95(23):1913-9. doi: 10.1136/hrt.2009.172072. Epub 2009 Aug 10.</citation>
    <PMID>19671534</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>October 28, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital San Carlos, Madrid</investigator_affiliation>
    <investigator_full_name>Nieves Gonzalo</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03026465
org study id: VISTA
nct id: NCT03026465
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of the present study is to determine the relation between vascular injury
      induced by the stent and strut thickness.
Thinner struts produce less arterial injury after stent implantation.The objective of the
      present study is to determine the relation between vascular injury induced by the stent and
      strut thickness. Vessel injury after stent implantation will be evaluated with optical
      coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex
      ISAR 50 microns and Biomatrix 120 microns) will be compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: OCT-based intimal injury score
time frame: Up to 1 day (evaluated after stent implantation)
description: OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES
measure: Tissue prolapse area
time frame: Up to 1 day (evaluated after stent implantation)
description: Tissue prolapse area assessed by OCT after implantation of Coroflex-ISAR and Biomatrix will be measured
measure: Incidence of stent malapposition
time frame: Up to 1 day (evaluated after stent implantation)
description: Stent apposition after implantation of Coroflex-ISAR and Biomatrix as assessed by OCT
measure: Incidence of stent underexpansion
time frame: Up to 1 day (evaluated after stent implantation)
description: Stent expansion will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix
measure: Stent symmetry after implantation
time frame: Up to 1 day (evaluated after stent implantation)
description: Stent symmetry will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix
measure: Baseline plaque type
time frame: Up to 1 day (evaluated after stent implantation)
description: Baseline plaque type will be assessed by OCT (fibrous, fibrocalcific or lipid-rich)
arm group label: Coroflex ISAR stent
arm group type: Experimental
description: PCI with a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR stent) with very thin struts (50 µm). During the PCI, an OCT assessment (baseline and post-implantation) will be performed.
arm group label: Biomatrix stent
arm group type: Active Comparator
description: PCI with a biodegradable-polymer biolimus-eluting stent (Biomatrix stent) with 120 µm struts. During the PCI, an OCT assessment (baseline and post-implantation) will be performed.
intervention type: Device
intervention name: Polymer-free stent
description: PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)
arm group label: Coroflex ISAR stent
other name: Coroflex ISAR
intervention type: Device
intervention name: Biodegradable-polymer stent
description: PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)
arm group label: Biomatrix stent
other name: Biomatrix
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nieves Gonzalo, MD, PhD
role: Study Director
affiliation: Hospital Clinico San Carlos de Madrid
facility: 
facility: 
facility: 
country: Spain
citation: Sullivan TM, Ainsworth SD, Langan EM, Taylor S, Snyder B, Cull D, Youkey J, Laberge M. Effect of endovascular stent strut geometry on vascular injury, myointimal hyperplasia, and restenosis. J Vasc Surg. 2002 Jul;36(1):143-9. doi: 10.1067/mva.2002.122878.
PMID: 12096272
citation: Hara H, Nakamura M, Palmaz JC, Schwartz RS. Role of stent design and coatings on restenosis and thrombosis. Adv Drug Deliv Rev. 2006 Jun 3;58(3):377-86. doi: 10.1016/j.addr.2006.01.022. Epub 2006 Mar 6.
PMID: 16650911
citation: Farb A, Weber DK, Kolodgie FD, Burke AP, Virmani R. Morphological predictors of restenosis after coronary stenting in humans. Circulation. 2002 Jun 25;105(25):2974-80. doi: 10.1161/01.cir.0000019071.72887.bd.
PMID: 12081990
citation: Rogers C, Edelman ER. Endovascular stent design dictates experimental restenosis and thrombosis. Circulation. 1995 Jun 15;91(12):2995-3001. doi: 10.1161/01.cir.91.12.2995.
PMID: 7796511
citation: Scott NA. Restenosis following implantation of bare metal coronary stents: pathophysiology and pathways involved in the vascular response to injury. Adv Drug Deliv Rev. 2006 Jun 3;58(3):358-76. doi: 10.1016/j.addr.2006.01.015. Epub 2006 Mar 6.
PMID: 16733073
citation: Foin N, Lee RD, Torii R, Guitierrez-Chico JL, Mattesini A, Nijjer S, Sen S, Petraco R, Davies JE, Di Mario C, Joner M, Virmani R, Wong P. Impact of stent strut design in metallic stents and biodegradable scaffolds. Int J Cardiol. 2014 Dec 20;177(3):800-8. doi: 10.1016/j.ijcard.2014.09.143. Epub 2014 Oct 7.
PMID: 25449502
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responsible party type: Principal Investigator
investigator affiliation: Hospital San Carlos, Madrid
investigator full name: Nieves Gonzalo
investigator title: MD, PhD
mesh term: Coronary Artery Disease
sharing ipd: No