Paclitaxel Eluting Balloon for SFA In-stent Restenosis

In-stent Arterial Restenosis Clinical Trial

Official title: Rug Eluting Balloon With Paclitaxel for Treatment of In-stent Restenosis in Femoropopliteal Arteries

Status Active, not recruiting

Clinical Trial Summary

The purpose of the study is to evaluate the safety and efficacy on the use of drug eluting balloon (DEB) with paclitaxel to treat in-stent restenosis in femoropopliteal arteries.

Clinical Trial Description

Peripheral artery disease (PAD) in the lower extremities can cause claudication, pain in the legs or feet and slowly wounds that can affect patients' quality of life and increase the risk of leg amputation and death. Both conventional balloon angioplasty (CBA) alone and CBA plus bare metal stents are the current primary endovascular therapy to treat PAD. However, exaggerated neointimal hyperplasia leading to in-stent restenosis is associated with CBA. Paclitaxel coated balloons have been recognized to be safe and effective for the treatment of coronary in-stent restenosis, which the investigators hypothesize to be applicable in femoropopliteal cases. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In-stent Arterial Restenosis

• NCT number: NCT01616888
• Study type: Interventional
• Source: University Health Network, Toronto
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2012
• Completion date: August 2015