AcoArt IV / SFA in China:Drug-eluting Balloon for SFA Angioplasty Evaluation in China
NCT03267056 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120
Last updated 2020-08-19
Summary
The registry is a prospective, multicenter, single arm post-market real-world registry in China assessing the clinical use, safety and outcomes of the Orchid 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).
Conditions
Interventions
- DEVICE
-
drug eluting balloon catheter (trade name: Orchid)
use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Sponsors & Collaborators
-
Acotec Scientific Co., Ltd
lead INDUSTRY
Principal Investigators
-
Wei Guo · Chinese PLA General Hospital
-
Yinghua Zou · Peking University First Hospital
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-01-19
- Primary Completion
- 2020-04-30
- Completion
- 2020-06-01
Countries
- China
Study Locations
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