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

Zhejiang Zylox Medical Device

Status: Completed

Conditions: Femoral Artery Occlusion; Popliteal Artery Occlusion; Popliteal Artery Stenosis; Femoral Artery Stenosis; Iliac Artery Occlusion; Peripheral Arterial Disease; Iliac Artery Stenosis

Treatments: Device: ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter; Device: Peripheral Balloon Dilatation Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03844724

ZYLOX2014001

Details and patient eligibility

About

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

Full 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.

Enrollment: 204 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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204 participants in 2 patient groups

Group A

Experimental group

Description:

subjects using the drug-eluting PTA balloon dilatation catheter

Treatment:

Device: ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter

Group B

Active Comparator group

Description:

subjects using the peripheral balloon dilatation catheter

Treatment:

Device: Peripheral Balloon Dilatation Catheter