Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses

Cook Group Incorporated11 sites in 2 countries176 target enrollmentFebruary 21, 2017

ConditionsPeripheral Arterial Disease (PAD)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease (PAD)
Sponsor: Cook Group Incorporated
Enrollment: 176
Locations: 11
Primary Endpoint: The percent diameter stenosis within the study lesion evaluated by conventional angiography.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.

Registry

clinicaltrials.gov

Start Date

February 21, 2017

End Date

October 25, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cook Group Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis
•Symptoms of peripheral arterial disease (Rutherford 2-4)

Exclusion Criteria

•Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
•Less than 18 years old
•Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
•Previous stent in the study vessel

Outcomes

Primary Outcomes

The percent diameter stenosis within the study lesion evaluated by conventional angiography.

Time Frame: 6 months

Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters.