Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT03316833
Status:
SUSPENDED
Last Update Posted:
2023-01-31
First Post:
2017-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Waiting for a protocol amendment to extend follow-up lenght', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-29', 'studyFirstSubmitDate': '2017-10-06', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'target lesion failure', 'timeFrame': '12 months', 'description': 'composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '36043326', 'type': 'DERIVED', 'citation': 'Tarantini G, Fovino LN, Varbella F, Trabattoni D, Caramanno G, Trani C, De Cesare N, Esposito G, Montorfano M, Musto C, Picchi A, Sheiban I, Gasparetto V, Ribichini FL, Cardaioli F, Sacca S, Cerrato E, Napodano M, Martinato M, Azzolina D, Ando G, Mugnolo A, Caruso M, Rossini R, Passamonti E, Teles RC, Rigattieri S, Gregori D, Tamburino C, Burzotta F. A large, prospective, multicentre study of left main PCI using a latest-generation zotarolimus-eluting stent: the ROLEX study. EuroIntervention. 2023 Feb 6;18(13):e1108-e1119. doi: 10.4244/EIJ-D-22-00454.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of unprotected left main coronary artery disease (ULMCAD), both isolated or in association with two- or three-vessel coronary artery disease.', 'detailedDescription': 'The ROLEX study is a prospective, non-randomized, European, multi-center registry.\n\nFour hundred and fifty patients with unprotected left main coronary artery disease (ULMCAD) will be enrolled at up to 40 European sites. The main objective of the study is to assess the safety and efficacy of the new-generation zotarolimus-eluting stent Resolute Onyx in the treatment of ULMCAD, both isolated or in association with two- or three-vessel coronary artery disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with unprotected left main coronary artery disease up to intermediate anatomical complexity (defined by a SYNTAX score \\<33), considered amenable for percutaneous coronary intervention (PCI).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject \\> 18 years old\n* ULMCAD with angiographic diameter stenosis \\>50% (if 50-70% evidence of FFR \\<0.80 or IVUS minimal lumen area \\<6.0 mm2 is recommended.\n* Silent ischemia, stable angina, unstable angina or non-ST elevation myocardial infarction\n* Ability to provide written informed consent and comply with follow-up for at least 2 years.\n\nExclusion Criteria:\n\n1. Clinical exclusion criteria:\n\n * Prior PCI on the left main trunk or prior CABG.\n * Concomitant indication to cardiac surgery (severe heart valve disease etc.)\n * Cardiogenic Shock (Killip\\>2)\n * Severe renal insufficiency (GFR \\<30 ml/min)\n * Known impaired left ventricular function (left ventricular ejection fraction \\<30%)\n * Inability to tolerate or comply with dual antiplatelet therapy for at least 1 year\n * Pregnancy or intention to become pregnant\n * Life expectancy less than 1 year\n * Other investigational drug or device studies that have not reached their primary endpoint\n2. Angiographic exclusion criteria:\n\n * Left main diameter stenosis \\<50%\n * SYNTAX score \\>33'}, 'identificationModule': {'nctId': 'NCT03316833', 'acronym': 'Rolex', 'briefTitle': 'The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'The ROLEX Registry (Revascularization Of LEft Main With Resolute onyX) A Multicenter Prospective Registry of the Onyx Resolute Stent for the Treatment of Unprotected Left Main Coronary Artery Disease.', 'orgStudyIdInfo': {'id': 'ROLEX_2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Resolute Onyx', 'type': 'DEVICE', 'description': 'Percutaneous coronary revascularization of patients with unprotected left main coronary artery disease up to intermediate anatomical complexity (defined by a SYNTAX score \\<33), must be performed with the exclusive use of drug-eluting stents of the Resolute Onyx TM family'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Padua', 'state': 'PD', 'country': 'Italy', 'facility': 'Azienda Ospedale Università Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Agrigento', 'country': 'Italy', 'facility': 'ASP 1 Agrigento - Ospedale San Giovanni di Dio', 'geoPoint': {'lat': 37.31065, 'lon': 13.57661}}, {'city': 'Arezzo', 'country': 'Italy', 'facility': 'Policlinico San Donato', 'geoPoint': {'lat': 43.46276, 'lon': 11.88068}}, {'city': 'Caserta', 'country': 'Italy', 'facility': 'Azienda Ospedaliera S.Anna e S.Sebastiano', 'geoPoint': {'lat': 41.07262, 'lon': 14.33231}}, {'city': 'Catania', 'country': 'Italy', 'facility': 'Ospedale Ferrarotto', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'city': 'Cosenza', 'country': 'Italy', 'facility': "Ospedale civile dell'Annunziata", 'geoPoint': {'lat': 39.2989, 'lon': 16.25307}}, {'city': 'Cremona', 'country': 'Italy', 'facility': 'Azienda Socio-Sanitaria Territoriale di Cremona', 'geoPoint': {'lat': 45.13325, 'lon': 10.02129}}, {'city': 'Cuneo', 'country': 'Italy', 'facility': 'Ospedale Santa Croce e Carle', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'city': 'Grosseto', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Grosseto', 'geoPoint': {'lat': 42.76296, 'lon': 11.10941}}, {'city': 'Lecce', 'country': 'Italy', 'facility': 'Ospedale Fazzi', 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Legnago', 'country': 'Italy', 'facility': 'Ospedale Mater Salutis', 'geoPoint': {'lat': 45.19365, 'lon': 11.30227}}, {'city': 'Messina', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Policlinico G.Martino', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'city': 'Mestre', 'country': 'Italy', 'facility': "Ospedale dell'angelo", 'geoPoint': {'lat': 45.49167, 'lon': 12.24538}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Centro cardiologico Monzino', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Mirano', 'country': 'Italy', 'facility': 'Ospedale di Mirano', 'geoPoint': {'lat': 45.49458, 'lon': 12.10775}}, {'city': 'Monselice', 'country': 'Italy', 'facility': 'Ospedali Riuniti Padova Sud "Madre Teresa di Calcutta"', 'geoPoint': {'lat': 45.239, 'lon': 11.74984}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Orbassano', 'country': 'Italy', 'facility': 'Azienda Ospedliera Universitaria San Luigi Gonzaga', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'city': 'Osio Sotto', 'country': 'Italy', 'facility': 'Policlinico San Marco', 'geoPoint': {'lat': 45.61608, 'lon': 9.58905}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'ARNAS Civico', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Pescara', 'country': 'Italy', 'facility': 'Ospedale Santo Spirito Santo', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'city': 'Peschiera del Garda', 'country': 'Italy', 'facility': 'Casa di Cura Dott. Pederzoli', 'geoPoint': {'lat': 45.43912, 'lon': 10.68614}}, {'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Bianchi Melacrino Morelli', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'city': 'Rivoli', 'country': 'Italy', 'facility': 'Ospedale degli infermi', 'geoPoint': {'lat': 45.07073, 'lon': 7.51465}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Azienda Ospedaliera San Camillo Forlanini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale Sandro Pertini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Policlinico Gemelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Siena', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Senese', 'geoPoint': {'lat': 43.31822, 'lon': 11.33064}}, {'city': 'Torino', 'country': 'Italy', 'facility': 'Ospedale Mauriziano Umberto I', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Integrata Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'city': 'Carnaxide', 'country': 'Portugal', 'facility': 'Hospital de Santa Cruz', 'geoPoint': {'lat': 38.72706, 'lon': -9.24671}}], 'overallOfficials': [{'name': 'Giuseppe Tarantini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Padova'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}