NCT03466151

RESOLUTE ONYX China RCT Study

A Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in Comparison With the Medtronic Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: Medtronic Vascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.

Detailed description

This study is a pre-Market, prospective, multi-center, open-label, randomized controlled trial. Subjects will be 1:1 randomized and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months (primary endpoint\_LLL), and annual assessments from 1-5 years).

Conditions

• Ischemic Heart Disease
• Stenotic Coronary Lesion
• Cardiovascular Diseases
• Arteriosclerosis
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System	Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
DEVICE	Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System	Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Timeline

• Start date: 2018-04-12
• Primary completion: 2021-02-12
• Completion: 2026-04-30
• First posted: 2018-03-15
• Last updated: 2025-12-03

Locations

2 sites across 1 country: China