- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03316833
The Rolex Registry (Revascularization Of LEft Main With Resolute onyX) (Rolex)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Agrigento, Italy
- ASP 1 Agrigento - Ospedale San Giovanni di Dio
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Arezzo, Italy
- Policlinico San Donato
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Caserta, Italy
- Azienda Ospedaliera S.Anna e S.Sebastiano
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Catania, Italy
- Ospedale Ferrarotto
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Cosenza, Italy
- Ospedale civile dell'Annunziata
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Cremona, Italy
- Azienda Socio-Sanitaria Territoriale di Cremona
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Cuneo, Italy
- Ospedale Santa Croce e Carle
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Grosseto, Italy
- Azienda Ospedaliera Grosseto
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Lecce, Italy
- Ospedale Fazzi
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Legnago, Italy
- Ospedale Mater Salutis
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Messina, Italy
- Azienda Ospedaliera Universitaria Policlinico G.Martino
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Mestre, Italy
- Ospedale dell'Angelo
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Milano, Italy
- Centro Cardiologico Monzino
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Milano, Italy
- Ospedale San Raffaele
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Mirano, Italy
- Ospedale di Mirano
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Monselice, Italy
- Ospedali Riuniti Padova Sud "Madre Teresa di Calcutta"
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Napoli, Italy
- Azienda Ospedaliera Universitaria Federico II
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Orbassano, Italy
- Azienda Ospedliera Universitaria San Luigi Gonzaga
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Osio Sotto, Italy
- Policlinico San Marco
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Palermo, Italy
- ARNAS civico
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Pavia, Italy
- Fondazione IRCCS Policlinico San Matteo
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Pescara, Italy
- Ospedale Santo Spirito Santo
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Peschiera Del Garda, Italy
- Casa di Cura Dott. Pederzoli
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Reggio Calabria, Italy
- Azienda Ospedaliera Bianchi Melacrino Morelli
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Rivoli, Italy
- Ospedale degli Infermi
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Roma, Italy
- Ospedale Sandro Pertini
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Roma, Italy
- Azienda Ospedaliera San Camillo Forlanini
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Roma, Italy
- Policlinico Gemelli
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Siena, Italy
- Azienda Ospedaliera Universitaria Senese
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Torino, Italy
- Ospedale Mauriziano Umberto I
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Verona, Italy
- Azienda Ospedaliera Universitaria Integrata Verona
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PD
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Padova, PD, Italy, 35128
- Azienda Ospedale Universita Padova
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-
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Carnaxide, Portugal
- Hospital de Santa Cruz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
target lesion failure
Time Frame: 12 months
|
composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Giuseppe Tarantini, MD, PhD, University of Padova
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ROLEX_2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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