Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
NCT03844724 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2019-02-18
Summary
Clinical study on safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter in the treatment of iliac, femoral and popliteal artery stenosis or occlusion
Conditions
- Peripheral Arterial Disease
- Iliac Artery Stenosis
- Femoral Artery Stenosis
- Popliteal Artery Stenosis
- Iliac Artery Occlusion
- Femoral Artery Occlusion
- Popliteal Artery Occlusion
Interventions
- DEVICE
-
ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter
Digital subtraction angiography(DSA)
- DEVICE
-
Peripheral Balloon Dilatation Catheter
Digital subtraction angiography(DSA)
Sponsors & Collaborators
-
Zhejiang Zylox Medical Device Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Changwei Liu · Peking Union Medical College 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
- 2015-04-10
- Primary Completion
- 2018-03-05
- Completion
- 2018-10-22
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