AcoArt Ⅱ/ BTK China: Drug-eluting Balloon for Below-The-Knee Angioplasty Evaluation in China
NCT02137577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2021-06-18
Summary
The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.
Conditions
Interventions
- PROCEDURE
-
DEB catheter
DEB catheter (trade name: Litos/Tulip)
- PROCEDURE
-
common PTA balloon catheter
common PTA balloon catheter
Sponsors & Collaborators
-
Acotec Scientific Co., Ltd
lead INDUSTRY
Principal Investigators
-
Wei Guo · Chinese PLA General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2018-11-30
- Completion
- 2020-12-17
Countries
- China
Study Locations
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