A Study of the SMART Stent in the Treatment SFA Disease. - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00232869

Purpose

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.

Condition	Intervention	Phase
Peripheral Artery Disease	Device: drug-eluting stent Device: bare-metal stent	Phase II

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Clinical Investigation of the SIROlimus Coated Cordis SMART™ Nitinol Selfexpandable Stent for the Treatment of Obstructive Superficial Femoral Artery Disease.

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

In-stent mean lumen diameter percent stenosis via quantitative angiography. [ Time Frame: 6 months. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	90
Study Start Date:	February 2001
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent	Device: drug-eluting stent Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
2: Active Comparator SMART™ bare-metal stent	Device: bare-metal stent SMART™ bare-metal 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.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232869

Locations

Germany
University Hospital
Tübingen, Germany, 72070

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:

Stephan H Duda, MD

Tübingen - Germany

More Information

Publications of Results:

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.

Responsible Party:	Cordis ( Dr. Hans-Peter Stoll )
Study ID Numbers:	EE00-02
Study First Received:	October 4, 2005
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00232869
Health Authority:	Germany: Ethics Commission; France: Institutional Ethical Committee; Netherlands: Independent Ethics Committee; United Kingdom: Research Ethics Committee; Canada: Ethics Review Committee; Australia: Human Research Ethics Committee

Study placed in the following topic categories:

Sirolimus

ClinicalTrials.gov processed this record on January 16, 2009