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

Zhejiang Zylox Medical Device Co., Ltd.204 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

204

Conditions

Peripheral Arterial Disease Iliac Artery Stenosis Femoral Artery Stenosis Popliteal Artery Stenosis

Interventions

ZENFlow™ Drug-eluting PTA Balloon Dilatation CatheterDEVICE

Digital subtraction angiography（DSA）

Peripheral Balloon Dilatation CatheterDEVICE

Digital subtraction angiography（DSA）

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Late Lumen Loss at 6 months after operation

Late Lumen Loss

Time frame: 6 months

Secondary Outcomes

The incidence of major adverse events

Related to death of clinical trials

Time frame: 12 months

Adverse Event

Adverse medical events, whether or not related to the medical device

Time frame: Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months