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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-10

Study Completion Date

2018-10-22

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

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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.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A

subjects using the drug-eluting PTA balloon dilatation catheter

Group Type EXPERIMENTAL

ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter

Intervention Type DEVICE

Digital subtraction angiography（DSA）

Group B

subjects using the peripheral balloon dilatation catheter

Group Type ACTIVE_COMPARATOR

Peripheral Balloon Dilatation Catheter

Intervention Type DEVICE

Digital subtraction angiography（DSA）

Interventions

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ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter

Digital subtraction angiography（DSA）

Intervention Type DEVICE

Peripheral Balloon Dilatation Catheter

Digital subtraction angiography（DSA）

Intervention Type DEVICE

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