Trials / Active Not Recruiting
Active Not RecruitingNCT03471845
RESOLUTE ONYX China Single Arm Study
A Single Arm Clinical Evaluation of Safety and Efficacy of the Medtronic Resolute Onyx™ 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
- 591 (actual)
- Sponsor
- Medtronic Vascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This study is a pre-Market, prospective, multi-center, single arm trial. Subjects will be enrolled and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, 6 Months, 9 Months-subjects implanted with fringe size, 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 |
Timeline
- Start date
- 2018-03-30
- Primary completion
- 2021-02-24
- Completion
- 2026-04-30
- First posted
- 2018-03-21
- Last updated
- 2025-11-26
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03471845. Inclusion in this directory is not an endorsement.