A Prospective, Multicenter, Randomized Controlled Trail Using Drug-coated Balloon to Treat Below The Knee Arterial Stenosis or Occlusion

Zhejiang Zylox Medical Device Co., Ltd.20 sites in 1 country202 target enrollmentMarch 1, 2022

ConditionsPeripheral Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Enrollment: 202
Locations: 20
Primary Endpoint: Rate of primary patency of the target lesion
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.

Detailed Description

This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.

Registry

clinicaltrials.gov

Start Date

March 1, 2022

End Date

December 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhejiang Zylox Medical Device Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-85 years；
•≥70% diameter stenosis or occlusion in the target below-the-knee lesion；
•Rutherford Category 3-6；
•Subjects are willing to sign informed consent；

Exclusion Criteria

•Planned major limb amputation within 30 days after the procedure;
•In-stent stenosis in the target lesion;
•Severely calcified target lesions；
•Creatinine\>2.5mg/dL;
•History of allergies to anesthetics, contrast agents；
•Subjects who have participated in any other drug or medical device clinical investigations and haven't reach the primary endpoint；
•Other circumstances judged by researchers that are not suitable for enrollment.