Balloon Angioplasty Versus Primary Stenting for the Treatment of Femoropopliteal Artery Chronic Total Occlusions — FACTORY  

Chronic Total Occlusion of Artery of the Extremities Clinical Trial

Official title: Balloon Angioplasty Versus Self-expanding Stent for Recanalization of Chronic Total Occlusions of the Femoral Artery

Status Recruiting

Clinical Trial Summary

This is a multicenter double-arm randomized trial investigating plain balloon angioplasty versus primary placement of self-expanding nitinol stents after endovascular recanalization of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for detection of a significant difference in vessel patency after 1 year.

Clinical Trial Description

Primary placement of new-generation nitinol stents compared to plain old balloon angioplasty has shown encouraging long-term results in the femoropopliteal artery. However, there is complete lack of data about performance of new-generation nitinol stents in the treatment of chronic total occlusions (CTO) of the Femoral artery. This is a multicenter double-arm randomized trial investigating plain balloon angioplasty versus primary placement of self-expanding nitinol stents after endovascular recanalization of femoral CTOs. Study will recruit up to 200 patients to be adequately powered for detection of a significant difference in vessel patency after 1 year. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Total Occlusion of Artery of the Extremities

• NCT number: NCT01268722
• Study type: Interventional
• Source: University of Patras
• Contact: Dimitrios Siablis, MD, PhD
• Phone: 2613603219
• Email: siablis@upatras.gr
• Status: Recruiting
• Phase: Phase 3
• Start date: December 2010
• Completion date: December 2016