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A Study of the SMART Stent in the Treatment SFA Disease. (SIROCCO)

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ClinicalTrials.gov Identifier: NCT00232869
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : February 4, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Peripheral Artery Disease Device: drug-eluting stent Device: bare-metal stent Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Investigation of the SIROlimus Coated Cordis SMART™ Nitinol Selfexpandable Stent for the Treatment of Obstructive Superficial Femoral Artery Disease.
Study Start Date : February 2001
Primary Completion Date : June 2003
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
Device: drug-eluting stent
Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
Active Comparator: 2
SMART™ bare-metal stent
Device: bare-metal stent
SMART™ bare-metal stent

Primary Outcome Measures :
  1. In-stent mean lumen diameter percent stenosis via quantitative angiography. [ Time Frame: 6 months. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232869

University Hospital
Tübingen, Germany, 72070
Sponsors and Collaborators
Cordis Corporation
Principal Investigator: Stephan H Duda, MD Tübingen - Germany

Responsible Party: Dr. Hans-Peter Stoll, Cordis
ClinicalTrials.gov Identifier: NCT00232869     History of Changes
Other Study ID Numbers: EE00-02
First Posted: October 5, 2005    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs