{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T17:50:15Z","timestamp":1791395415691,"version":"4.3.3"},"reference-count":20,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T00:00:00Z","timestamp":1765929600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2025,12,17]],"date-time":"2025-12-17T00:00:00Z","timestamp":1765929600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cathet Cardio Intervent"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Moderate\u2010to\u2010severe calcification is present in ~20%\u201330% of patients undergoing coronary angiography. Coronary lesion modification is often necessary to facilitate optimal stent delivery and expansion, with several dedicated devices now approved for calcium modification before stent implantation. The CYCLOPES study aims to evaluate an intravascular ultrasound (IVUS) based calcium modification algorithm for the treatment of moderate\u2010to\u2010severely calcified coronary lesions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and Analysis<\/jats:title>\n                    <jats:p>CYCLOPES is a prospective, international, multi\u2010center, observational, single\u2010arm study. 500 patients will be enrolled at 25 centers in Europe. Patients with planned percutaneous coronary intervention (PCI) to a native coronary artery lesion with moderate\u2010to\u2010severe calcification will be eligible. All PCI procedures will be IVUS guided, with drug\u2010eluting stents implanted according to the study\u2010specific algorithm.<\/jats:p>\n                    <jats:p>The co\u2010primary endpoints are the minimum stent area (MSA) at the site of maximum calcification at the end of the index procedure (as determined by core lab analysis), and target lesion failure (TLF) at 1\u2010year post\u2010procedure. Prespecified secondary endpoints include: the individual components of TLF at 1 month and 1 year; the MSA measured at the end of the index procedure; strategy success (defined as successful stent delivery with \u2265\u200980% stent expansion and complete stent apposition with no significant edge dissection and full lesion coverage with &lt;\u200950% plaque burden at proximal and distal references with TIMI 3 flow); as well as target vessel revascularization; target lesion revascularization; stent thrombosis; cardiovascular death; and acute kidney injury at 1 year. Coronary angiograms and IVUS images will be analyzed by an independent core Lab. Clinical follow\u2010up will be performed at discharge, 30\u2010days, and 1 year post PCI.<\/jats:p>\n                    <jats:p>Trial Registration: ClinicalTrials.gov identifier: NCT06678594.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ccd.70424","type":"journal-article","created":{"date-parts":[[2025,12,18]],"date-time":"2025-12-18T05:01:06Z","timestamp":1766034066000},"page":"1018-1026","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A Prospective, Multicenter, Open Label Study Investigating the Implementation of a Standardized Algorithm for Coronary CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES): Design and Rationale of the CYCLOPES Trial"],"prefix":"10.1002","volume":"107","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4480-9990","authenticated-orcid":false,"given":"Daniel","family":"O'Callaghan","sequence":"first","affiliation":[{"name":"Department of Cardiology Cardiovascular Research Institute (CVRI) and Mater Private Network Dublin Ireland"},{"name":"RCSI School of Medicine and Health Sciences Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2712-2131","authenticated-orcid":false,"given":"Rory","family":"Durand","sequence":"additional","affiliation":[{"name":"Department of Cardiology Cardiovascular Research Institute (CVRI) and Mater Private Network Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colm G.","family":"Hanratty","sequence":"additional","affiliation":[{"name":"Department of Cardiology Cardiovascular Research Institute (CVRI) and Mater Private Network Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Cuisset","sequence":"additional","affiliation":[{"name":"CHU Timone Marseille France"},{"name":"CV2N, INSERM, INRAE Aix Marseille University Marseille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatriz","family":"Vaquerizo","sequence":"additional","affiliation":[{"name":"Hospital del Mar, IMIM Universidad Aut\u00f3noma Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jan\u2010Malte","family":"Sinning","sequence":"additional","affiliation":[{"name":"St. Vincent Hospital Cologne Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"O'Kane","sequence":"additional","affiliation":[{"name":"Dorset Heart Centre, Royal Bournemouth Hospital University Hospitals Dorset Bournemouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6086-3279","authenticated-orcid":false,"given":"J. J.","family":"Coughlan","sequence":"additional","affiliation":[{"name":"Department of Cardiology Cardiovascular Research Institute (CVRI) and Mater Private Network Dublin Ireland"},{"name":"RCSI School of Medicine and Health Sciences Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Walsh","sequence":"additional","affiliation":[{"name":"Belfast Health &amp; Social Care Trust Belfast UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ro\u0301isi\u0301n","family":"Colleran","sequence":"additional","affiliation":[{"name":"Department of Cardiology Cardiovascular Research Institute (CVRI) and Mater Private Network Dublin Ireland"},{"name":"RCSI School of Medicine and Health Sciences Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Himanshu","family":"Rai","sequence":"additional","affiliation":[{"name":"Department of Cardiology Cardiovascular Research Institute (CVRI) and Mater Private Network Dublin Ireland"},{"name":"RCSI School of Medicine and Health Sciences Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osama","family":"Soliman","sequence":"additional","affiliation":[{"name":"Department of Cardiology Cardiovascular Research Institute (CVRI) and Mater Private Network Dublin Ireland"},{"name":"RCSI School of Medicine and Health Sciences Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emanuele","family":"Barbato","sequence":"additional","affiliation":[{"name":"University Hospital Sant'Andrea Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara E.","family":"St\u00e4hli","sequence":"additional","affiliation":[{"name":"University Hospital Zurich, Faculty of Medicine University of Zurich Zurich Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert A.","family":"Byrne","sequence":"additional","affiliation":[{"name":"Department of Cardiology Cardiovascular Research Institute (CVRI) and Mater Private Network Dublin Ireland"},{"name":"RCSI School of Medicine and Health Sciences Dublin Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,12,17]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacc.2014.01.034"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijcard.2016.12.150"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/heartjnl-2013-305180"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCINTERVENTIONS.118.007415"},{"key":"e_1_2_7_6_1","unstructured":"N. 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