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Completed

NCT Number: NCT03844724

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

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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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Femoral Artery Occlusion Femoral Artery Stenosis Iliac Artery Occlusion Iliac Artery Stenosis Peripheral Vascular Diseases Popliteal Artery Occlusion Popliteal Artery Stenosis Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter

Device

Digital subtraction angiography（DSA）

Peripheral Balloon Dilatation Catheter

Device

Digital subtraction angiography（DSA）

Primary outcomes

  1. Late Lumen Loss at 6 months after operation

    Time frame: 6 months

    Late Lumen Loss

Secondary outcomes

  1. The incidence of major adverse events

    Time frame: 12 months

    Related to death of clinical trials

  2. Adverse Event

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

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

Sponsors and collaborators

Lead sponsor

Zhejiang Zylox Medical Device Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Feb 18, 2019
Registry last updated
Feb 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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