NCT00232869

A Study of the SMART Stent in the Treatment SFA Disease.

A Clinical Investigation of the SIROlimus Coated Cordis SMART™ Nitinol Selfexpandable Stent for the Treatment of Obstructive Superficial Femoral Artery Disease.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (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 safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery (SFA) disease in reducing percent in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to the uncoated SMART™ stent.

Detailed description

This is a multi-center, prospective, randomized, double blind, two-arm feasibility study evaluating the safety and performance of the sirolimus coated Cordis SMART™ nitinol self-expanding stent and delivery system as compared to the uncoated SMART™ stent and delivery system. It is anticipated that a total of 90 patients will be entered into the study. Patients will be randomized on a 1:1 basis of coated to uncoated stents. Ninety (90) patients with de novo or restenotic native SFA lesions will be randomized to the Sirolimus Coated SMART™ nitinol self-expanding stent or to the uncoated (bare) SMART™ stent. Patients will be followed for 24 months post-procedure, with all patients having duplex ultrasound and clinical assessments at discharge, 1, 6, 9, 18 and 24 months, angiography at 6 six months and plain X-ray at 18 months. This study will be conducted at nine investigational sites. (Protocol was amended where 56 additional patients were recruited and followed for up to 5 years.)

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	drug-eluting stent	Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
DEVICE	bare-metal stent	SMART™ bare-metal stent

Timeline

• Start date: 2001-02-01
• Primary completion: 2003-06-01
• Completion: 2009-05-01
• First posted: 2005-10-05
• Last updated: 2010-02-04

Locations

1 site across 1 country: Germany