MedTrace Logo

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

NCT03316833 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2023-01-31

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Giuseppe Tarantini, MD, PhD · University of Padova

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2021-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • Italy
  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03316833 on ClinicalTrials.gov