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

Suspended

• Conditions: Coronary Artery Disease

• Registration Number: NCT03316833
• Lead Sponsor: University of Padova

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.

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 Timeline

• Study First Submitted: 2017-10-06
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Study Start: 2017-11-01
• Primary Completion: 2021-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-29
• Last Update Posted: 2023-01-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
target lesion failure	12 months	composite of cardiac death, target vessel myocardial infarction and ischemia-driven target lesion revascularization

Trial Locations

Locations (33)

Azienda Ospedale Università Padova; 🇮🇹 Padova, PD, 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

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