NCT00235131

The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent

A Clinical Investigation of the Cordis S.M.A.R.T. ™ CONTROL ™ Nitinol Stent System Versus the Bard® Luminexx™ 6F Vascular Stent for the Treatment of TASC C & D Superficial Femoral Artery Long Lesions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C \& D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure.

Detailed description

This is a German multi-center prospective, randomized, two-arm study evaluating performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard® Luminexx™ 6F Vascular Stent. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 200 patients will be entered into the study. The study population will consist of approximately 200 symptomatic peripheral vascular disease patients with TASC C \& D SFA lesions. The disease will consist of symptomatic, long de novo or restenotic lesions (\> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic imaging. The lesion must not extend into the distal SFA and the popliteal artery. At least one distal popliteal artery must be patent as well as one calf vessel. Reference vessel diameter must be \>= 4.0 to \<= 6.0 mm. Trial participants will be randomized to the Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System or to the Bard® Luminexx™ 6F Vascular Stent. Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure. This study will be conducted over up to 15 investigational sites in Germany.

Conditions

• Arterial Occlusive Diseases

Interventions

Type	Name	Description
DEVICE	Smart Stent	Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
DEVICE	Luminexx Stent	Bard® Luminexx™ 6F Vascular Stent

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-03-01
• Completion: 2009-05-01
• First posted: 2005-10-10
• Last updated: 2010-02-04

Locations

2 sites across 1 country: Germany