<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/NCT02238054</url>
  </required_header>
  <id_info>
    <org_study_id>14249</org_study_id>
    <nct_id>NCT02238054</nct_id>
  </id_info>
  <brief_title>French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS</brief_title>
  <acronym>FRANCE-ABSORB</acronym>
  <official_title>French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>French Cardiology Society</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>French Cardiology Society</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Observational Study, French, prospective, multicenter rated using intravascular prosthesis&#xD;
      ABSORB BVS.&#xD;
&#xD;
      ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all&#xD;
      procedures for coronary angioplasty with implantation of at least one BVS with a clinical&#xD;
      follow-up of all patients implanted with ABSORB BVS. This national observatory will collect&#xD;
      all the events related to product and / or to procedure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">May 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Major Adverse Cardiac Events at 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>At 1 year of follow-up, to evaluate the rate of MACE (Major Adverse Cardiac Events) defined as follows:&#xD;
Death from cardiac causes&#xD;
Myocardial Infarction&#xD;
Rates of target lesion revascularization (TLR) of ischemic origin (ID-TLR)&#xD;
Surgery unscheduled bypass graft (CABG)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularization at 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>At 1 year of follow-up, to evaluate the rate of target vessel revascularization (TVR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of stent thrombosis at 1 year</measure>
    <time_frame>1 year</time_frame>
    <description>At 1 year of follow-up, to evaluate the rate of stent thrombosis as ARC definitions :&#xD;
acute, subacute, late&#xD;
probable or undoubted</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2072</enrollment>
  <condition>Intracoronary Angioplasty</condition>
  <arm_group>
    <arm_group_label>ABSORB BVS</arm_group_label>
    <description>All patients with a coronary angioplasty procedure and the implantation of at least one ABSORB BVS</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All the departments of Cardiology, from French health institutions, who are authorized to&#xD;
        implement, may participate in the observatory.&#xD;
&#xD;
        It is estimated that this procedure will be performed by 50 to 60 sites performing the&#xD;
        installation of BVS. The list of centers is scalable, their number can be expected to&#xD;
        increase.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient affiliated to the National Health Insurance Scheme&#xD;
&#xD;
          -  Patient able to assess and understand the risks, benefits and alternative treatments&#xD;
             laying of ABSORB, to agree to participate in the study (by signing the informed&#xD;
             consent after having read the newsletter)&#xD;
&#xD;
          -  Patients for whom a procedure is performed coronary angioplasty with implantation of&#xD;
             at least one BVS.&#xD;
&#xD;
          -  Patient allowing the follow-up as defined in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patient&#xD;
&#xD;
          -  Patient that can not give informed consent&#xD;
&#xD;
          -  Patient with in-stent restenosis or saphenous vein bypass&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinique Saint Hilaire</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.</citation>
    <PMID>2950322</PMID>
  </reference>
  <reference>
    <citation>Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201.</citation>
    <PMID>449946</PMID>
  </reference>
  <reference>
    <citation>Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.</citation>
    <PMID>8041413</PMID>
  </reference>
  <reference>
    <citation>Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. doi: 10.1056/NEJMra051091. No abstract available.</citation>
    <PMID>16452560</PMID>
  </reference>
  <reference>
    <citation>Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.</citation>
    <PMID>12050336</PMID>
  </reference>
  <reference>
    <citation>Abbott JD, Voss MR, Nakamura M, Cohen HA, Selzer F, Kip KE, Vlachos HA, Wilensky RL, Williams DO. Unrestricted use of drug-eluting stents compared with bare-metal stents in routine clinical practice: findings from the National Heart, Lung, and Blood Institute Dynamic Registry. J Am Coll Cardiol. 2007 Nov 20;50(21):2029-36. doi: 10.1016/j.jacc.2007.07.071.</citation>
    <PMID>18021868</PMID>
  </reference>
  <reference>
    <citation>Ormiston JA, Serruys PW, Regar E, Dudek D, Thuesen L, Webster MW, Onuma Y, Garcia-Garcia HM, McGreevy R, Veldhof S. A bioabsorbable everolimus-eluting coronary stent system for patients with single de-novo coronary artery lesions (ABSORB): a prospective open-label trial. Lancet. 2008 Mar 15;371(9616):899-907. doi: 10.1016/S0140-6736(08)60415-8.</citation>
    <PMID>18342684</PMID>
  </reference>
  <reference>
    <citation>Serruys PW, Ormiston JA, Onuma Y, Regar E, Gonzalo N, Garcia-Garcia HM, Nieman K, Bruining N, Dorange C, Miquel-Hebert K, Veldhof S, Webster M, Thuesen L, Dudek D. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet. 2009 Mar 14;373(9667):897-910. doi: 10.1016/S0140-6736(09)60325-1.</citation>
    <PMID>19286089</PMID>
  </reference>
  <reference>
    <citation>Serruys PW, Onuma Y, Ormiston JA, de Bruyne B, Regar E, Dudek D, Thuesen L, Smits PC, Chevalier B, McClean D, Koolen J, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Miquel-Hebert K, Rapoza R, Garcia-Garcia HM. Evaluation of the second generation of a bioresorbable everolimus drug-eluting vascular scaffold for treatment of de novo coronary artery stenosis: six-month clinical and imaging outcomes. Circulation. 2010 Nov 30;122(22):2301-12. doi: 10.1161/CIRCULATIONAHA.110.970772. Epub 2010 Nov 15.</citation>
    <PMID>21098436</PMID>
  </reference>
  <reference>
    <citation>Serruys PW, Onuma Y, Dudek D, Smits PC, Koolen J, Chevalier B, de Bruyne B, Thuesen L, McClean D, van Geuns RJ, Windecker S, Whitbourn R, Meredith I, Dorange C, Veldhof S, Hebert KM, Sudhir K, Garcia-Garcia HM, Ormiston JA. Evaluation of the second generation of a bioresorbable everolimus-eluting vascular scaffold for the treatment of de novo coronary artery stenosis: 12-month clinical and imaging outcomes. J Am Coll Cardiol. 2011 Oct 4;58(15):1578-88. doi: 10.1016/j.jacc.2011.05.050.</citation>
    <PMID>21958884</PMID>
  </reference>
  <reference>
    <citation>Dudek D, Onuma Y, Ormiston JA, Thuesen L, Miquel-Hebert K, Serruys PW. Four-year clinical follow-up of the ABSORB everolimus-eluting bioresorbable vascular scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2012 Jan;7(9):1060-1. doi: 10.4244/EIJV7I9A168.</citation>
    <PMID>21959320</PMID>
  </reference>
  <reference>
    <citation>Ormiston J, Webster M. Absorbable coronary stents. Lancet. 2007 Jun 2;369(9576):1839-1840. doi: 10.1016/S0140-6736(07)60829-0. No abstract available.</citation>
    <PMID>17544749</PMID>
  </reference>
  <reference>
    <citation>Ramcharitar S, Serruys PW. Fully biodegradable coronary stents : progress to date. Am J Cardiovasc Drugs. 2008;8(5):305-14. doi: 10.2165/00129784-200808050-00003.</citation>
    <PMID>18828642</PMID>
  </reference>
  <reference>
    <citation>Macaya C, Moreno R. Bioabsorbable drug-eluting stents: the future of coronary angioplasty? Nat Clin Pract Cardiovasc Med. 2008 Oct;5(10):598-9. doi: 10.1038/ncpcardio1306. Epub 2008 Aug 5.</citation>
    <PMID>18679382</PMID>
  </reference>
  <reference>
    <citation>Colombo A, Sharp AS. The bioabsorbable stent as a virtual prosthesis. Lancet. 2009 Mar 14;373(9667):869-70. doi: 10.1016/S0140-6736(09)60521-3. No abstract available.</citation>
    <PMID>19286066</PMID>
  </reference>
  <reference>
    <citation>Ormiston JA, Serruys PW. Bioabsorbable coronary stents. Circ Cardiovasc Interv. 2009 Jun;2(3):255-60. doi: 10.1161/CIRCINTERVENTIONS.109.859173. No abstract available.</citation>
    <PMID>20031723</PMID>
  </reference>
  <reference>
    <citation>Onuma Y, Piazza N, Ormiston JA, Serruys PW. Everolimus-eluting bioabsorbable stent--Abbot Vascular programme. EuroIntervention. 2009 Dec 15;5 Suppl F:F98-F102. doi: 10.4244/EIJV5IFA17. No abstract available.</citation>
    <PMID>22100687</PMID>
  </reference>
  <reference>
    <citation>Oberhauser JP, Hossainy S, Rapoza RJ. Design principles and performance of bioresorbable polymeric vascular scaffolds. EuroIntervention. 2009 Dec 15;5 Suppl F:F15-22. doi: 10.4244/EIJV5IFA3.</citation>
    <PMID>22100671</PMID>
  </reference>
  <reference>
    <citation>Onuma Y, Serruys PW, Ormiston JA, Regar E, Webster M, Thuesen L, Dudek D, Veldhof S, Rapoza R. Three-year results of clinical follow-up after a bioresorbable everolimus-eluting scaffold in patients with de novo coronary artery disease: the ABSORB trial. EuroIntervention. 2010 Sep;6(4):447-53. doi: 10.4244/EIJ30V6I4A76.</citation>
    <PMID>20884431</PMID>
  </reference>
  <reference>
    <citation>Bittl JA. Bioresorbable stents: the next revolution. Circulation. 2010 Nov 30;122(22):2236-8. doi: 10.1161/CIRCULATIONAHA.110.988469. Epub 2010 Nov 15. No abstract available.</citation>
    <PMID>21098438</PMID>
  </reference>
  <reference>
    <citation>Diletti R, Onuma Y, Farooq V, Gomez-Lara J, Brugaletta S, van Geuns RJ, Regar E, de Bruyne B, Dudek D, Thuesen L, Chevalier B, McClean D, Windecker S, Whitbourn R, Smits P, Koolen J, Meredith I, Li D, Veldhof S, Rapoza R, Garcia-Garcia HM, Ormiston JA, Serruys PW. 6-month clinical outcomes following implantation of the bioresorbable everolimus-eluting vascular scaffold in vessels smaller or larger than 2.5 mm. J Am Coll Cardiol. 2011 Jul 12;58(3):258-64. doi: 10.1016/j.jacc.2011.02.052.</citation>
    <PMID>21737016</PMID>
  </reference>
  <reference>
    <citation>Gori T, Schulz E, Hink U, Wenzel P, Post F, Jabs A, Munzel T. Early outcome after implantation of Absorb bioresorbable drug-eluting scaffolds in patients with acute coronary syndromes. EuroIntervention. 2014 Jan 22;9(9):1036-41. doi: 10.4244/EIJV9I9A176.</citation>
    <PMID>23999237</PMID>
  </reference>
  <reference>
    <citation>Simsek C, Magro M, Onuma Y, Boersma E, Smits P, Dorange C, Veldhof S, Regar E, Serruys PW, van Geuns RJ. Procedural and clinical outcomes of the Absorb everolimus-eluting bioresorbable vascular scaffold: one-month results of the Bioresorbable vascular Scaffold Evaluated At Rotterdam Cardiology Hospitals (B-SEARCH). EuroIntervention. 2014 Jun;10(2):236-40. doi: 10.4244/EIJV10I2A38.</citation>
    <PMID>23999210</PMID>
  </reference>
  <reference>
    <citation>Meincke F, Kuck KH, Bergmann MW. Delivery of a bioresorbable vascular scaffold to complex lesions. Catheter Cardiovasc Interv. 2014 Nov 1;84(5):774-8. doi: 10.1002/ccd.25105. Epub 2014 Jul 30.</citation>
    <PMID>23907893</PMID>
  </reference>
  <reference>
    <citation>Kajiya T, Liang M, Sharma RK, Lee CH, Chan MY, Tay E, Chan KH, Tan HC, Low AF. Everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in patients with ST-segment elevation myocardial infarction (STEMI). EuroIntervention. 2013 Aug 22;9(4):501-4. doi: 10.4244/EIJV9I4A80.</citation>
    <PMID>23687101</PMID>
  </reference>
  <reference>
    <citation>Gogas BD, Bourantas CV, Garcia-Garcia HM, Onuma Y, Muramatsu T, Farooq V, Diletti R, van Geuns RJ, De Bruyne B, Chevalier B, Thuesen L, Smits PC, Dudek D, Koolen J, Windecker S, Whitbourn R, McClean D, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Ormiston JA, Serruys PW. The edge vascular response following implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold and the XIENCE V metallic everolimus-eluting stent. First serial follow-up assessment at six months and two years: insights from the first-in-man ABSORB Cohort B and SPIRIT II trials. EuroIntervention. 2013 Oct;9(6):709-20. doi: 10.4244/EIJV9I6A115.</citation>
    <PMID>23628499</PMID>
  </reference>
  <reference>
    <citation>Diletti R, Serruys PW, Farooq V, Sudhir K, Dorange C, Miquel-Hebert K, Veldhof S, Rapoza R, Onuma Y, Garcia-Garcia HM, Chevalier B. ABSORB II randomized controlled trial: a clinical evaluation to compare the safety, efficacy, and performance of the Absorb everolimus-eluting bioresorbable vascular scaffold system against the XIENCE everolimus-eluting coronary stent system in the treatment of subjects with ischemic heart disease caused by de novo native coronary artery lesions: rationale and study design. Am Heart J. 2012 Nov;164(5):654-63. doi: 10.1016/j.ahj.2012.08.010.</citation>
    <PMID>23137495</PMID>
  </reference>
  <reference>
    <citation>Diletti R, Farooq V, Girasis C, Bourantas C, Onuma Y, Heo JH, Gogas BD, van Geuns RJ, Regar E, de Bruyne B, Dudek D, Thuesen L, Chevalier B, McClean D, Windecker S, Whitbourn RJ, Smits P, Koolen J, Meredith I, Li X, Miquel-Hebert K, Veldhof S, Garcia-Garcia HM, Ormiston JA, Serruys PW. Clinical and intravascular imaging outcomes at 1 and 2 years after implantation of absorb everolimus eluting bioresorbable vascular scaffolds in small vessels. Late lumen enlargement: does bioresorption matter with small vessel size? Insight from the ABSORB cohort B trial. Heart. 2013 Jan;99(2):98-105. doi: 10.1136/heartjnl-2012-302598. Epub 2012 Oct 31.</citation>
    <PMID>23118346</PMID>
  </reference>
  <reference>
    <citation>Garcia-Garcia HM, Schultz C, Duckers E, Regar E, Ligthart J, Serruys PW, van Geuns RJ. Five-year follow-up of the ABSORB bioresorbable everolimus-eluting vascular scaffold system: multimodality imaging assessment. EuroIntervention. 2013 Feb 22;8(10):1126-7. doi: 10.4244/EIJV8I10A187. No abstract available.</citation>
    <PMID>23014900</PMID>
  </reference>
  <reference>
    <citation>Gogas BD, Farooq V, Onuma Y, Serruys PW. The ABSORB bioresorbable vascular scaffold: an evolution or revolution in interventional cardiology? Hellenic J Cardiol. 2012 Jul-Aug;53(4):301-9. No abstract available.</citation>
    <PMID>22796817</PMID>
  </reference>
  <reference>
    <citation>Brugaletta S, Garcia-Garcia HM, Onuma Y, Serruys PW. Everolimus-eluting ABSORB bioresorbable vascular scaffold: present and future perspectives. Expert Rev Med Devices. 2012 Jul;9(4):327-38. doi: 10.1586/erd.12.17. Epub 2012 Mar 16.</citation>
    <PMID>22420293</PMID>
  </reference>
  <reference>
    <citation>Gomez-Lara J, Diletti R, Brugaletta S, Onuma Y, Farooq V, Thuesen L, McClean D, Koolen J, Ormiston JA, Windecker S, Whitbourn R, Dudek D, Dorange C, Veldhof S, Rapoza R, Regar E, Garcia-Garcia HM, Serruys PW. Angiographic maximal luminal diameter and appropriate deployment of the everolimus-eluting bioresorbable vascular scaffold as assessed by optical coherence tomography: an ABSORB cohort B trial sub-study. EuroIntervention. 2012 Jun 20;8(2):214-24. doi: 10.4244/EIJV8I2A35.</citation>
    <PMID>22030265</PMID>
  </reference>
  <reference>
    <citation>Sarno G, Bruining N, Onuma Y, Garg S, Brugaletta S, De Winter S, Regar E, Thuesen L, Dudek D, Veldhof S, Dorange C, Garcia-Garcia HM, Ormiston JA, Serruys PW. Morphological and functional evaluation of the bioresorption of the bioresorbable everolimus-eluting vascular scaffold using IVUS, echogenicity and vasomotion testing at two year follow-up: a patient level insight into the ABSORB A clinical trial. Int J Cardiovasc Imaging. 2012 Jan;28(1):51-8. doi: 10.1007/s10554-010-9769-y. Epub 2011 Jan 7.</citation>
    <PMID>21213050</PMID>
  </reference>
  <results_reference>
    <citation>Cayla G, Koning R, Fajadet J, Sainsous J, Carrie D, Elhadad S, Tarragano F, Lefevre T, Ranc S, Ghostine S, Garot P, Marco F, Maillard L, Motreff P, Le Breton H; FRANCE ABSORB investigators. Percutaneous coronary interventions with the Absorb Bioresorbable vascular scaffold in real life: 1-year results from the FRANCE ABSORB registry. Arch Cardiovasc Dis. 2019 Feb;112(2):113-123. doi: 10.1016/j.acvd.2018.09.007. Epub 2019 Jan 7.</citation>
    <PMID>30630761</PMID>
  </results_reference>
  <results_reference>
    <citation>Lhermusier T, Carrie D, Cayla G, Fajadet J, Sainsous J, Elhadad S, Tarragano F, Chevalier B, Ranc S, Curinier C, Le Breton H, Koning R; FRANCE ABSORB Investigators. Three-year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry. Catheter Cardiovasc Interv. 2021 Sep;98(3):511-519. doi: 10.1002/ccd.29369. Epub 2020 Nov 19.</citation>
    <PMID>33211387</PMID>
  </results_reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cardiology</keyword>
  <keyword>Intracoronary angioplasty</keyword>
  <keyword>Bioresorbable stent</keyword>
  <!-- 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/NCT02238054
org study id: 14249
nct id: NCT02238054
lead sponsor: 
has dmc: Yes
Observational Study, French, prospective, multicenter rated using intravascular prosthesis
      ABSORB BVS.

      ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all
      procedures for coronary angioplasty with implantation of at least one BVS with a clinical
      follow-up of all patients implanted with ABSORB BVS. This national observatory will collect
      all the events related to product and / or to procedure
observational model: Cohort
time perspective: Prospective
measure: Major Adverse Cardiac Events at 1 year
time frame: 1 year
description: At 1 year of follow-up, to evaluate the rate of MACE (Major Adverse Cardiac Events) defined as follows:
Death from cardiac causes
Myocardial Infarction
Rates of target lesion revascularization (TLR) of ischemic origin (ID-TLR)
Surgery unscheduled bypass graft (CABG)
measure: Target vessel revascularization at 1 year
time frame: 1 year
description: At 1 year of follow-up, to evaluate the rate of target vessel revascularization (TVR)
measure: Rate of stent thrombosis at 1 year
time frame: 1 year
description: At 1 year of follow-up, to evaluate the rate of stent thrombosis as ARC definitions :
acute, subacute, late
probable or undoubted
arm group label: ABSORB BVS
description: All patients with a coronary angioplasty procedure and the implantation of at least one ABSORB BVS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
citation: Sigwart U, Puel J, Mirkovitch V, Joffre F, Kappenberger L. Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. N Engl J Med. 1987 Mar 19;316(12):701-6. doi: 10.1056/NEJM198703193161201.
PMID: 2950322
citation: Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. doi: 10.1056/NEJM197907123010201.
PMID: 449946
citation: Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.
PMID: 8041413
citation: Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. doi: 10.1056/NEJMra051091. No abstract available.
PMID: 16452560
citation: Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002 Jun 6;346(23):1773-80. doi: 10.1056/NEJMoa012843.
PMID: 12050336
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responsible party type: Sponsor