RESOLUTE ONYX China Single Arm Study
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 585
Summary
- Conditions
- Arteriosclerosis
- Cardiovascular Diseases
- Coronary (Artery) Disease
- Ischemic Heart Disease
- Stenotic Coronary Lesion
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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).
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).
Tracking Information
- NCT #
- NCT03471845
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ben He, MD Shanghai Chest Hospital
Get Well Soon