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

University of Padova

Status: Suspended

Conditions: Coronary Artery Disease

Treatments: Device: Resolute Onyx

Study type: Observational

Funder types: Other

Identifiers

NCT03316833

ROLEX_2017

Details and patient eligibility

About

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.

Full 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

Enrollment: 450 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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