{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:22:11Z","timestamp":1790619731175,"version":"4.1.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"38","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2015,10,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix\u2002Supplementary Data of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force\u2019s report.<\/jats:p>","DOI":"10.1093\/eurheartj\/ehv203","type":"journal-article","created":{"date-parts":[[2015,6,13]],"date-time":"2015-06-13T20:11:02Z","timestamp":1434226262000},"page":"2608-2620","source":"Crossref","is-referenced-by-count":213,"title":["Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary"],"prefix":"10.1093","volume":"36","author":[{"given":"Robert A.","family":"Byrne","sequence":"first","affiliation":[{"name":"1 Deutsches Herzzentrum M\u00fcnchen, Technische Universit\u00e4t M\u00fcnchen, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick W.","family":"Serruys","sequence":"additional","affiliation":[{"name":"2 Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Baumbach","sequence":"additional","affiliation":[{"name":"Bristol Heart Institute 3 , Bristol ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Escaned","sequence":"additional","affiliation":[{"name":"Hospital San Carlos 4 Interventional Cardiology , , Madrid ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean","family":"Fajadet","sequence":"additional","affiliation":[{"name":"Clinique Pasteur 5 Interventional Cardiology , , Toulouse ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan","family":"James","sequence":"additional","affiliation":[{"name":"Uppsala University 6 Clinical Research Center , , Uppsala ,","place":["Sweden"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Joner","sequence":"additional","affiliation":[{"name":"CVPath Institute, Inc. 7 , Gaithersburg ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Semih","family":"Oktay","sequence":"additional","affiliation":[{"name":"Cardio Med Device Consultants 8 , Baltimore ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"J\u00fcni","sequence":"additional","affiliation":[{"name":"University of Bern 9 Institute of Primary Health Care (BIHAM) , , Bern ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adnan","family":"Kastrati","sequence":"additional","affiliation":[{"name":"1 Deutsches Herzzentrum M\u00fcnchen, Technische Universit\u00e4t M\u00fcnchen, Munich, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"George","family":"Sianos","sequence":"additional","affiliation":[{"name":"AHEPA University Hospital 10 , Thessaloniki ,","place":["Greece"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulio G.","family":"Stefanini","sequence":"additional","affiliation":[{"name":"Bern University Hospital 11 Swiss Cardiovascular Center Bern , , Bern ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Wijns","sequence":"additional","affiliation":[{"name":"Cardiovascular Center O.L.V.Z. 12 , Aalst ,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Windecker","sequence":"additional","affiliation":[{"name":"Bern University Hospital 11 Swiss Cardiovascular Center Bern , , Bern ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2015,6,13]]},"reference":[{"key":"2026080919372489300_EHV203C1","first-page":"64","article-title":"Clinical evaluation of medical devices: light at the end of the tunnel?","volume":"36","author":"Fraser","year":"2015","journal-title":"Eur Heart J"},{"key":"2026080919372489300_EHV203C2","author":"Council Directive 93\/42\/EEC of 14 June 1993 concerning medical devices"},{"key":"2026080919372489300_EHV203C3"},{"key":"2026080919372489300_EHV203C4","doi-asserted-by":"crossref","first-page":"1673","DOI":"10.1093\/eurheartj\/ehr171","article-title":"Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. 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