The Rolex Registry (Revascularization Of LEft Main With Resolute onyX) (Rolex)

May 6, 2022 updated by: University of Padova

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.

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.

Study Overview

Status

Active, not recruiting

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

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Agrigento, Italy
        • ASP 1 Agrigento - Ospedale San Giovanni di Dio
      • Arezzo, Italy
        • Policlinico San Donato
      • Caserta, Italy
        • Azienda Ospedaliera S.Anna e S.Sebastiano
      • Catania, Italy
        • Ospedale Ferrarotto
      • Cosenza, Italy
        • Ospedale civile dell'Annunziata
      • Cremona, Italy
        • Azienda Socio-Sanitaria Territoriale di Cremona
      • Cuneo, Italy
        • Ospedale Santa Croce e Carle
      • Grosseto, Italy
        • Azienda Ospedaliera Grosseto
      • Lecce, Italy
        • Ospedale Fazzi
      • Legnago, Italy
        • Ospedale Mater Salutis
      • Messina, Italy
        • Azienda Ospedaliera Universitaria Policlinico G.Martino
      • Mestre, Italy
        • Ospedale dell'Angelo
      • Milano, Italy
        • Centro Cardiologico Monzino
      • Milano, Italy
        • Ospedale San Raffaele
      • Mirano, Italy
        • Ospedale di Mirano
      • Monselice, Italy
        • Ospedali Riuniti Padova Sud "Madre Teresa di Calcutta"
      • Napoli, Italy
        • Azienda Ospedaliera Universitaria Federico II
      • Orbassano, Italy
        • Azienda Ospedliera Universitaria San Luigi Gonzaga
      • Osio Sotto, Italy
        • Policlinico San Marco
      • Palermo, Italy
        • ARNAS civico
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San Matteo
      • Pescara, Italy
        • Ospedale Santo Spirito Santo
      • Peschiera Del Garda, Italy
        • Casa di Cura Dott. Pederzoli
      • Reggio Calabria, Italy
        • Azienda Ospedaliera Bianchi Melacrino Morelli
      • Rivoli, Italy
        • Ospedale degli Infermi
      • Roma, Italy
        • Ospedale Sandro Pertini
      • Roma, Italy
        • Azienda Ospedaliera San Camillo Forlanini
      • Roma, Italy
        • Policlinico Gemelli
      • Siena, Italy
        • Azienda Ospedaliera Universitaria Senese
      • Torino, Italy
        • Ospedale Mauriziano Umberto I
      • Verona, Italy
        • Azienda Ospedaliera Universitaria Integrata Verona
    • PD
      • Padova, PD, Italy, 35128
        • Azienda Ospedale Universita Padova
      • Carnaxide, Portugal
        • Hospital de Santa Cruz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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).

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:

  1. 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
  2. Angiographic exclusion criteria:

    • Left main diameter stenosis <50%
    • SYNTAX score >33

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Giuseppe Tarantini, MD, PhD, University of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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