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Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease — ACHILLES  

Peripheral Arterial Diseases Clinical Trial

Official title:
A Prospective, Randomized, Multicenter Comparison of Balloon Angioplasty and the Cypher Selecttm + Coronary and Infrapopliteal Stent in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease

Clinical Trial Summary

The primary objective of this study is to compare the performance of the CYPHER SELECTTM + Sirolimus-eluting Balloon-expandable Coronary and Infrapopliteal Stent over balloon angioplasty in de novo and restenotic native below the knee tibioperoneal, anterior and/or posterior tibial and/or peroneal arterial lesions in a prospective, multicenter, randomized clinical study.

Clinical Trial Description

This is a multicenter, prospective, randomized study to be conducted in 18 centers in Europe. A total of 200 subjects will be entered into the study and will be randomized on a 1:1 basis to either balloon angioplasty or the CYPHER SELECTTM + Coronary and Infrapopliteal Stent for infrapopliteal use in subjects with symptomatic peripheral artery disease (Rutherford 3, 4, or 5).

All subjects will undergo a repeat angiography at 12 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 6 weeks, 6 and 12 months. ;

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00640770
Study type Interventional
Source Cordis Corporation
Contact
Status Completed
Phase Phase 4
Start date March 2008
Completion date January 2011
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