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

Peripheral Artery Disease Clinical Trial

— SIROCCO  

Official title:

A Clinical Investigation of the SIROlimus Coated Cordis SMART™ Nitinol Selfexpandable Stent for the Treatment of Obstructive Superficial Femoral Artery Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232869
• Other study ID #: EE00-02
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2005
• Last updated: February 3, 2010
• Start date: February 2001
• Est. completion date: May 2009

Study information

• Verified date: February 2010
• Source: Cordis Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionFrance: Institutional Ethical CommitteeNetherlands: Independent Ethics CommitteeUnited Kingdom: Research Ethics CommitteeCanada: Ethics Review CommitteeAustralia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: May 2009
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• drug-eluting stent
Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent
• bare-metal stent
SMART™ bare-metal stent

Locations

Country	Name	City	State
Germany	University Hospital	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 superfi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent mean lumen diameter percent stenosis via quantitative angiography.		6 months.	Yes