The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent

Arterial Occlusive Diseases Clinical Trial

— SUPER SL  

Official title:

A Clinical Investigation of the Cordis S.M.A.R.T. ™ CONTROL ™ Nitinol Stent System Versus the Bard® Luminexx™ 6F Vascular Stent for the Treatment of TASC C & D Superficial Femoral Artery Long Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235131
• Other study ID #: EE04-02
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2005
• Last updated: February 3, 2010
• Start date: May 2005
• 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 Commission
• Study type: Interventional

Clinical Trial Summary

This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C & D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure.

Description:

This is a German multi-center prospective, randomized, two-arm study evaluating performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard® Luminexx™ 6F Vascular Stent. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 200 patients will be entered into the study.

The study population will consist of approximately 200 symptomatic peripheral vascular disease patients with TASC C & D SFA lesions. The disease will consist of symptomatic, long de novo or restenotic lesions (> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic imaging. The lesion must not extend into the distal SFA and the popliteal artery. At least one distal popliteal artery must be patent as well as one calf vessel. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.

Trial participants will be randomized to the Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System or to the Bard® Luminexx™ 6F Vascular Stent.

Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.

This study will be conducted over up to 15 investigational sites in Germany.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Symptomatic leg ischemia by Rutherford classification (category 2, 3, 4 or 5); duration of intermittent claudication (category 2-3) should be at least 3 months.

• One superficial femoral artery de novo or restenotic lesion (more than 70% stenosis or occlusions), with a lesion length of more than 5 to less than 22 cm.

• Patent popliteal artery on the index side, i.e., single vessel runoff or better with at least one of three vessels patent to the lower 1/3 of the calf prior to the day of the procedure.

Exclusion Criteria:

• Revascularisation involving the same limb within 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure.

• Patients having total occlusions of the iliac artery on the same side must be excluded.

• Previously implanted stent(s) in the to be treated artery at the same site.

• Requiring stent placement in the distal superficial femoral artery and the popliteal artery.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

Device:
• Smart Stent
Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
• Luminexx Stent
Bard® Luminexx™ 6F Vascular Stent

Locations

Country	Name	City	State
Germany	Gemeinschaftspraxis füsar Radiologische Diagnostik& Zentrum für Minimal Invasite Therapie am Jüdischen Krankenhaus Berlin	Berlin
Germany	Universitat Leipzig Herzzentrum Abt. Für Klinische u. Intervent. Angiologie	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
Cordis Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	primary patency detectable by duplex ultrasound through the index lesion		12 months	Yes
Secondary	technical success		time of deployment	No
Secondary	procedural success		up to removal of catheter sheath	No
Secondary	procedural complications		up to removal of catheter sheath	Yes
Secondary	Ankle Brachial Index		discharge and 12 months	Yes
Secondary	primary patency		6 months	Yes
Secondary	binary restenosis		6 and 12 months	Yes
Secondary	stent fractures		6 and 12 months	Yes
Secondary	target lesion revascularisation		6 and 12 months	Yes
Secondary	target vessel revascularisation		6 and 12 months	Yes
Secondary	adverse events		baseline, discharge, 6 and 12 months post procedure	Yes
Secondary	clinical categorization of chronic limb ischemia by means of the Rutherford classification		discharge, 6 and 12 months post procedure	Yes