DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis
NCT05608655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188
Last updated 2024-02-20
Summary
A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis
Conditions
- Femoral Artery Stenosis
- Popliteal Artery Stenosis
Interventions
- DEVICE
-
DKutting LL balloon
After pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
- DEVICE
-
Chocolate balloon
After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment
Sponsors & Collaborators
-
DK Medical Technology (Suzhou) Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Weiguo Fu, Dr. · Shanghai Zhongshan Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-27
- Primary Completion
- 2024-01-10
- Completion
- 2024-02-04
Countries
- China
Study Locations
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