Trials / Completed
CompletedNCT03844724
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Safety and Efficacy of ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Iliac, Femoral and Popliteal Artery Stenosis or Occlusion
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 204 (actual)
- Sponsor
- Zhejiang Zylox Medical Device Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Detailed description
The purpose of this study was to evaluate the safety and efficacy of ZENFlow™ drug-eluting PTA balloon dilatation catheter (paclitaxel 3±1 μg/mm2 balloon surface area) in the treatment of iliac artery, femoral artery and popliteal stenosis or occlusive lesions compared with conventional PTA balloon dilatation catheter.
Conditions
- Peripheral Arterial Disease
- Iliac Artery Stenosis
- Femoral Artery Stenosis
- Popliteal Artery Stenosis
- Iliac Artery Occlusion
- Femoral Artery Occlusion
- Popliteal Artery Occlusion
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter | Digital subtraction angiography（DSA） |
| DEVICE | Peripheral Balloon Dilatation Catheter | Digital subtraction angiography（DSA） |
Timeline
- Start date
- 2015-04-10
- Primary completion
- 2018-03-05
- Completion
- 2018-10-22
- First posted
- 2019-02-18
- Last updated
- 2019-02-18
Source: ClinicalTrials.gov record NCT03844724. Inclusion in this directory is not an endorsement.