Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Iliac, Femoral and Popliteal Artery Stenosis or Occlusion

Conditions
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Peripheral Arterial Disease, Iliac Artery Stenosis, Femoral Artery Stenosis, Popliteal Artery Stenosis, Iliac Artery Occlusion, Femoral Artery Occlusion, Popliteal Artery Occlusion

Intervention / Treatment
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* Device: ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter
* Device: Peripheral Balloon Dilatation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Pregnant woman or who's pregnancy test is positive Lactation period woman or woman/man with fertility plan

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>subjects using the drug-eluting PTA balloon dilatation catheter | Device: ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter<br>* Digital subtraction angiography（DSA）<br>|
| Active Comparator: Group B<br>subjects using the peripheral balloon dilatation catheter | Device: Peripheral Balloon Dilatation Catheter<br>* Digital subtraction angiography（DSA）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Lumen Loss at 6 months after operation | Late Lumen Loss | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of major adverse events | Related to death of clinical trials | 12 months | 
| Adverse Event | Adverse medical events, whether or not related to the medical device | Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Drug-eluting PTA Balloon Dilatation Catheter, Late Lumen Loss（6 months）