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

Key facts

Who runs it
University of Padova
Where
Italy and Portugal33 sites in 2 countriesChoose a country to see its sites
Trial code
Status
Suspended
People taking part
450 people enrolled
Started
1 Nov 2017
Ended
31 Dec 2025
Type of study
Observational
Treatments tested
  • Resolute Onyx
Record updated
31 January 2023
Why it stopped
Waiting for a protocol amendment to extend follow-up lenght

Who can take part

Age
18 years to 99 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Angiographic exclusion criteria:; Left main diameter stenosis <50%; SYNTAX score >33

This trial has no sites in United States.

It has sites in 2 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Treatments tested

  • Resolute Onyx

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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.
Record updated
31 January 2023