The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)
NCT ID: NCT03316833
Last Updated: 2023-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
450 participants
OBSERVATIONAL
2017-11-01
2025-12-31
Brief Summary
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Detailed Description
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Four 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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Resolute Onyx
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
Eligibility Criteria
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Inclusion Criteria
* ULMCAD with angiographic diameter stenosis \>50% (if 50-70% evidence of FFR \<0.80 or IVUS minimal lumen area \<6.0 mm2 is recommended.
* Silent ischemia, stable angina, unstable angina or non-ST elevation myocardial infarction
* Ability to provide written informed consent and comply with follow-up for at least 2 years.
Exclusion Criteria
* Concomitant indication to cardiac surgery (severe heart valve disease etc.)
* Cardiogenic Shock (Killip\>2)
* Severe renal insufficiency (GFR \<30 ml/min)
* Known impaired left ventricular function (left ventricular ejection fraction \<30%)
* Inability to tolerate or comply with dual antiplatelet therapy for at least 1 year
* Pregnancy or intention to become pregnant
* Life expectancy less than 1 year
* Other investigational drug or device studies that have not reached their primary endpoint
* Left main diameter stenosis \<50%
* SYNTAX score \>33
18 Years
99 Years
ALL
No
Sponsors
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University of Padova
OTHER
Responsible Party
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Principal Investigators
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Giuseppe Tarantini, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Padova
Locations
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Ospedale San Raffaele
Milan, , Italy
Ospedale di Mirano
Mirano, , Italy
Ospedali Riuniti Padova Sud "Madre Teresa di Calcutta"
Monselice, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedale Università Padova
Padua, PD, Italy
ASP 1 Agrigento - Ospedale San Giovanni di Dio
Agrigento, , Italy
Policlinico San Donato
Arezzo, , Italy
Azienda Ospedaliera S.Anna e S.Sebastiano
Caserta, , Italy
Ospedale Ferrarotto
Catania, , Italy
Ospedale civile dell'Annunziata
Cosenza, , Italy
Azienda Socio-Sanitaria Territoriale di Cremona
Cremona, , Italy
Ospedale Santa Croce e Carle
Cuneo, , Italy
Azienda Ospedaliera Grosseto
Grosseto, , Italy
Ospedale Fazzi
Lecce, , Italy
Ospedale Mater Salutis
Legnago, , Italy
Azienda Ospedaliera Universitaria Policlinico G.Martino
Messina, , Italy
Ospedale dell'angelo
Mestre, , Italy
Centro cardiologico Monzino
Milan, , Italy
Azienda Ospedliera Universitaria San Luigi Gonzaga
Orbassano, , Italy
Policlinico San Marco
Osio Sotto, , Italy
ARNAS Civico
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Ospedale Santo Spirito Santo
Pescara, , Italy
Casa di Cura Dott. Pederzoli
Peschiera del Garda, , Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
Reggio Calabria, , Italy
Ospedale degli infermi
Rivoli, , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Ospedale Sandro Pertini
Roma, , Italy
Policlinico Gemelli
Roma, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Ospedale Mauriziano Umberto I
Torino, , Italy
Azienda Ospedaliera Universitaria Integrata Verona
Verona, , Italy
Hospital de Santa Cruz
Carnaxide, , Portugal
Countries
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References
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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.
Other Identifiers
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ROLEX_2017
Identifier Type: -
Identifier Source: org_study_id
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