A Clinical Trial to Evaluate the Efficacy and Safety of a Spot Stent System Used in Femoropopliteal Arteries.
NCT05246410 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196
Last updated 2023-11-29
Summary
A prospective randomized trial designed to compare the efficacy and safety of spot stent system versus self-expanding peripheral stent system in the endovascular treatment of femoropopliteal arterial stenotic disease.
Conditions
- Peripheral Vascular Disease (PVD)
- Peripheral Arterial Disease (PAD)
Interventions
- DEVICE
-
Spot stent system
Spot stent system designed and produced by Acotec
- DEVICE
-
Self-expanding peripheral stent system
Self-expanding peripheral stent system designed and produced by Ev3, Inc
Sponsors & Collaborators
-
Acotec Scientific Co., Ltd
lead INDUSTRY
Principal Investigators
-
Guo Wei, MD · Chinese PLA General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-17
- Primary Completion
- 2024-11-28
- Completion
- 2024-12-30
Countries
- China
Study Locations
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