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

Sponsor
University of Padova (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03316833
Collaborator
(none)
450
Enrollment
33
Locations
62
Anticipated Duration (Months)
13.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Resolute Onyx

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 Design

Study Type:
Observational
Actual Enrollment :
450 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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.
Actual Study Start Date :
Nov 1, 2017
Actual Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Outcome Measures

Primary Outcome Measures

  1. target lesion failure [12 months]

    composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Angiographic exclusion criteria:

  • Left main diameter stenosis <50%

  • SYNTAX score >33

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Ospedale Università Padova Padova PD Italy 35128
2 ASP 1 Agrigento - Ospedale San Giovanni di Dio Agrigento Italy
3 Policlinico San Donato Arezzo Italy
4 Azienda Ospedaliera S.Anna e S.Sebastiano Caserta Italy
5 Ospedale Ferrarotto Catania Italy
6 Ospedale civile dell'Annunziata Cosenza Italy
7 Azienda Socio-Sanitaria Territoriale di Cremona Cremona Italy
8 Ospedale Santa Croce e Carle Cuneo Italy
9 Azienda Ospedaliera Grosseto Grosseto Italy
10 Ospedale Fazzi Lecce Italy
11 Ospedale Mater Salutis Legnago Italy
12 Azienda Ospedaliera Universitaria Policlinico G.Martino Messina Italy
13 Ospedale dell'angelo Mestre Italy
14 Centro cardiologico Monzino Milano Italy
15 Ospedale San Raffaele Milano Italy
16 Ospedale di Mirano Mirano Italy
17 Ospedali Riuniti Padova Sud "Madre Teresa di Calcutta" Monselice Italy
18 Azienda Ospedaliera Universitaria Federico II Napoli Italy
19 Azienda Ospedliera Universitaria San Luigi Gonzaga Orbassano Italy
20 Policlinico San Marco Osio Sotto Italy
21 ARNAS Civico Palermo Italy
22 Fondazione IRCCS Policlinico San Matteo Pavia Italy
23 Ospedale Santo Spirito Santo Pescara Italy
24 Casa di Cura Dott. Pederzoli Peschiera Del Garda Italy
25 Azienda Ospedaliera Bianchi Melacrino Morelli Reggio Calabria Italy
26 Ospedale degli infermi Rivoli Italy
27 Azienda Ospedaliera San Camillo Forlanini Roma Italy
28 Ospedale Sandro Pertini Roma Italy
29 Policlinico Gemelli Roma Italy
30 Azienda Ospedaliera Universitaria Senese Siena Italy
31 Ospedale Mauriziano Umberto I Torino Italy
32 Azienda Ospedaliera Universitaria Integrata Verona Verona Italy
33 Hospital de Santa Cruz Carnaxide Portugal

Sponsors and Collaborators

  • University of Padova

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Padova
ClinicalTrials.gov Identifier:
NCT03316833
Other Study ID Numbers:
  • ROLEX_2017
First Posted:
Oct 20, 2017
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
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
Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease

Study Results

No Results Posted as of May 9, 2022