NCT00232843

The Study to Treat Superficial Femoral Artery Occlusions.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (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 performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as determined by binary restenosis at one year.

Detailed description

This is a multi-center, prospective, randomized, two-arm study evaluating the performance of the Cordis SMART™ nitinol self-expanding stent as compared to angioplasty only. It is anticipated that a total of 150 patients will be entered into the study. Patients will be randomized on a 1:1 basis of stent versus angioplasty only. 150 patients with de novo or restenotic native SFA occlusions (5-22 cm) with reference vessel of \>= 4.0 to \<= 6.0 mm in diameter will be randomized to the SMART™ nitinol self-expanding stent or to angioplasty only. All patients will be followed for 12 months post-procedure, by telephone contact at 3 and 6 months, and a 12 month clinical and duplex ultrasound assessment. This study will be conducted at up to 12 investigational sites.

Conditions

• Arterial Occlusive Diseases

Interventions

Type	Name	Description
DEVICE	stent	Cordis SMART™ nitinol self-expanding stent.
DEVICE	angioplasty	balloon angioplasty

Timeline

• Start date: 2005-03-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2005-10-05
• Last updated: 2009-06-03

Locations

2 sites across 1 country: United Kingdom