RESOLUTE ONYX China Single Arm Study
NCT03471845 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 591
Last updated 2026-04-21
Summary
It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.
Conditions
- Ischemic Heart Disease
- Stenotic Coronary Lesion
- Cardiovascular Diseases
- Arteriosclerosis
- Coronary Artery Disease
Interventions
- DEVICE
-
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
Sponsors & Collaborators
-
Medtronic Vascular
lead INDUSTRY
Principal Investigators
-
Ben He, MD · Shanghai Chest Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-30
- Primary Completion
- 2021-02-24
- Completion
- 2026-08-30
Countries
- China
Study Locations
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