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NCT03844724 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03844724
Other study ID # ZYLOX2014001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2015
Est. completion date October 22, 2018

Study information
Verified date February 2019
Source Zhejiang Zylox Medical Device Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 204
Est. completion date October 22, 2018
Est. primary completion date March 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter
Digital subtraction angiography(DSA)
• Peripheral Balloon Dilatation Catheter
Digital subtraction angiography(DSA)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhejiang Zylox Medical Device Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Late Lumen Loss at 6 months after operation Late Lumen Loss 6 months
Secondary The incidence of major adverse events Related to death of clinical trials 12 months
Secondary Adverse Event 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
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