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Part of the paucity of clinical data stems from the fact that prior studies have been suboptimally designed and performed. The absence of standardized end points and the discrepancy in definitions also prevent consistency and uniform interpretability of reported results in CTO intervention. To standardize the field, we therefore assembled a broad consortium comprising academicians, practicing physicians, researchers, medical society representatives, and regulators (US Food and Drug Administration) to develop methods, end points, biomarkers, parameters, data, materials, processes, procedures, evaluations, tools, and techniques for CTO interventions. This article summarizes the effort and is organized into 3 sections: key elements and procedural definitions, end point definitions, and clinical trial design principles. The Chronic Total Occlusion Academic Research Consortium is a first step toward improved comparability and interpretability of study results, supplying an increasingly growing body of CTO percutaneous coronary intervention evidence.<\/jats:p>","DOI":"10.1161\/circulationaha.120.046754","type":"journal-article","created":{"date-parts":[[2022,3,19]],"date-time":"2022-03-19T05:01:14Z","timestamp":1647666074000},"page":"479-500","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":295,"title":["Definitions and Clinical Trial Design Principles for Coronary Artery Chronic Total Occlusion Therapies: CTO-ARC Consensus Recommendations"],"prefix":"10.1161","volume":"143","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5837-5476","authenticated-orcid":true,"given":"Luiz F.","family":"Ybarra","sequence":"first","affiliation":[{"name":"London Health Sciences Centre, Schulich School of Medicine and Dentistry, Western University, Ontario, Canada (L.F.Y.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5321-4905","authenticated-orcid":true,"given":"St\u00e9phane","family":"Rinfret","sequence":"additional","affiliation":[{"name":"McGill University Health Centre, McGill University, Montreal, Quebec, Canada (S.R.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9416-9701","authenticated-orcid":true,"given":"Emmanouil S.","family":"Brilakis","sequence":"additional","affiliation":[{"name":"Minneapolis Heart Institute and Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, MN (E.S.B.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitri","family":"Karmpaliotis","sequence":"additional","affiliation":[{"name":"New York\u2013Presbyterian Hospital\/Columbia University Medical Center, NY (D.K., Z.A.A., A.M., J.W.M.)."},{"name":"The Cardiovascular Research Foundation, New York, NY (D.K., A.M., Z.A.A., J.W.M., G.W.S.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9758-0360","authenticated-orcid":true,"given":"Lorenzo","family":"Azzalini","sequence":"additional","affiliation":[{"name":"Cardiac Catheterization Laboratory, Mount Sinai Hospital, New York, NY (L.A.)."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. 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