The Rolex Registry (Revascularization Of LEft Main With Resolute onyX)
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT03316833
- Lead Sponsor
- University of Padova
- Brief Summary
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.
- Detailed Description
The ROLEX study is a prospective, non-randomized, European, multi-center registry.
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
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 450
- Subject > 18 years old
- 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.
-
Clinical exclusion criteria:
- Prior PCI on the left main trunk or prior CABG.
- 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
-
Angiographic exclusion criteria:
- Left main diameter stenosis <50%
- SYNTAX score >33
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method target lesion failure 12 months composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Azienda Ospedale Università Padova
🇮🇹Padova, 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 Mater Salutis
🇮🇹Legnago, Italy
Ospedale Fazzi
🇮🇹Lecce, Italy
Ospedale dell'angelo
🇮🇹Mestre, Italy
Azienda Ospedaliera Universitaria Policlinico G.Martino
🇮🇹Messina, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Centro cardiologico Monzino
🇮🇹Milano, Italy
Ospedale di Mirano
🇮🇹Mirano, Italy
ARNAS Civico
🇮🇹Palermo, Italy
Ospedali Riuniti Padova Sud "Madre Teresa di Calcutta"
🇮🇹Monselice, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, Italy
Azienda Ospedliera Universitaria San Luigi Gonzaga
🇮🇹Orbassano, Italy
Policlinico San Marco
🇮🇹Osio Sotto, Italy
Fondazione IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Casa di Cura Dott. Pederzoli
🇮🇹Peschiera Del Garda, Italy
Ospedale Santo Spirito Santo
🇮🇹Pescara, 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
Azienda Ospedaliera Bianchi Melacrino Morelli
🇮🇹Reggio Calabria, Italy