NCT02936622

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease (PAD)

Interventions

Type	Name	Description
DEVICE	Zilver® Paclitaxel-Eluting Peripheral Stent	Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
DEVICE	Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating	Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
DEVICE	Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating	Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Timeline

• Start date: 2017-02-21
• Primary completion: 2019-04-23
• Completion: 2023-10-25
• First posted: 2016-10-18
• Last updated: 2024-04-05

Locations

11 sites across 2 countries: Germany, New Zealand