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

Phase 2

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: drug-eluting stent; Device: bare-metal stent

• Registration Number: NCT00232869
• Lead Sponsor: Cordis Corporation

Brief 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.)

Study Timeline

• Study Start: 2001-02
• Primary Completion: 2003-06
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-04
• Study First Posted: 2005-10-05
• Study Completion: 2009-05
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

1. One superficial femoral artery presenting > 70% stenosis(es) or total occlusion
2. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4)

Exclusion Criteria

1. Tissue loss due to ischemic disease (Rutherford category 5 or 6).
2. Tandem lesion requiring non overlapping stents;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	drug-eluting stent	Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
2	bare-metal stent	SMART™ bare-metal stent

Primary Outcome Measures

Name	Time	Method
In-stent mean lumen diameter percent stenosis via quantitative angiography.	6 months.

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Tübingen, Germany