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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Italy
      • 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
  • Portugal
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 95 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Padova

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ROLEX_2017

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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