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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00232869
First received: October 4, 2005
Last updated: February 3, 2010
Last verified: February 2010
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 93
Study Start Date: February 2001
Study Completion Date: May 2009
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.)

  Eligibility

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

Responsible Party: Dr. Hans-Peter Stoll, Cordis
ClinicalTrials.gov Identifier: NCT00232869     History of Changes
Other Study ID Numbers: EE00-02
Study First Received: October 4, 2005
Last Updated: February 3, 2010
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

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

ClinicalTrials.gov processed this record on May 22, 2013