Status:
COMPLETED
Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion
Lead Sponsor:
Zhejiang Zylox Medical Device Co., Ltd.
Conditions:
Peripheral Arterial Disease
Iliac Artery Stenosis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Aged from 18 to 85 years old, male or female
- Subject's target lesions were stenosis and/or occlusion
- Subjects were able to understand the purpose of the study, demonstrate full compliance with the program and sign informed consent
Exclusion
- Pregnant woman or who's pregnancy test is positive
- Lactation period woman or woman/man with fertility plan
Key Trial Info
Start Date :
April 10 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2018
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT03844724
Start Date
April 10 2015
End Date
October 22 2018
Last Update
February 18 2019
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