NCT00289055

The Study to Compare the Treatment of Angioplasty and Stents in SFA Occlusions.

A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty for the Treatment of Superficial Femoral Artery Occlusions

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cordis US Corp. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.

Detailed description

This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study. The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be \>= 4.0 to \<= 6.0 mm. Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only. 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 at 8 investigational sites in The Netherlands.

Conditions

• Arterial Occlusive Diseases

Interventions

Type	Name	Description
DEVICE	stent	Cordis SMART™ Nitinol Stent
DEVICE	angioplasty	balloon angioplasty

Timeline

• Start date: 2005-11-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-02-09
• Last updated: 2009-02-24

Locations

1 site across 1 country: Netherlands