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

Coronary Artery Disease Clinical Trial

— Rolex  

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.

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03316833
• Other study ID #: ROLEX_2017
• Status: Suspended
• Start date: November 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 450
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Resolute Onyx
Percutaneous coronary revascularization of patients with unprotected left main coronary artery disease up to intermediate anatomical complexity (defined by a SYNTAX score <33), must be performed with the exclusive use of drug-eluting stents of the Resolute Onyx TM family

Locations

Country	Name	City	State
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 Fazzi	Lecce
Italy	Ospedale Mater Salutis	Legnago
Italy	Azienda Ospedaliera Universitaria Policlinico G.Martino	Messina
Italy	Ospedale dell'angelo	Mestre
Italy	Centro cardiologico Monzino	Milano
Italy	Ospedale San Raffaele	Milano
Italy	Ospedale di Mirano	Mirano
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	Azienda Ospedale Università Padova	Padova	PD
Italy	ARNAS Civico	Palermo
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Ospedale Santo Spirito Santo	Pescara
Italy	Casa di Cura Dott. Pederzoli	Peschiera Del Garda
Italy	Azienda Ospedaliera Bianchi Melacrino Morelli	Reggio Calabria
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
Portugal	Hospital de Santa Cruz	Carnaxide

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Countries where clinical trial is conducted

Italy,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target lesion failure	composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization	12 months