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

February 15, 2019 updated by: Zhejiang Zylox Medical Device Co., Ltd.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of major adverse events
Time Frame: 12 months
Related to death of clinical trials
12 months
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
Preoperative、Intraoperative、up to 1 month、3 months、6 months、9 months、12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

Investigators

  • Principal Investigator: Changwei Liu, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2015

Primary Completion (Actual)

March 5, 2018

Study Completion (Actual)

October 22, 2018

Study Registration Dates

First Submitted

February 13, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZYLOX2014001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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