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

NCT ID: NCT00232869

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2009-05-31

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.)

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent

Group Type: EXPERIMENTAL

drug-eluting stent

Intervention Type: DEVICE

Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent

2

SMART™ bare-metal stent

Group Type: ACTIVE_COMPARATOR

bare-metal stent

Intervention Type: DEVICE

SMART™ bare-metal stent

Interventions

drug-eluting stent

Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent

Intervention Type: DEVICE

bare-metal stent

SMART™ bare-metal stent

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Cordis

Principal Investigators

Stephan H Duda, MD

Role: PRINCIPAL_INVESTIGATOR

Tübingen - Germany

Locations

University Hospital

Tübingen, , Germany

Countries

Germany

References

Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006 Dec;13(6):701-10. doi: 10.1583/05-1704.1.

Reference Type: RESULT

PMID: 17154704 (View on PubMed)

Other Identifiers

EE00-02

Identifier Type: -

Identifier Source: org_study_id