NCT03316833

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

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.

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 450 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-01
• Primary completion: 2021-12-31
• Completion: 2025-12-31
• First posted: 2017-10-20
• Last updated: 2023-01-31

Locations

33 sites across 2 countries: Italy, Portugal

Regulatory

• FDA-regulated device study