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

Phase 4

Completed

• Conditions: Arterial Occlusive Diseases
• Interventions: Device: Smart Stent; Device: Luminexx Stent

• Registration Number: NCT00235131
• Lead Sponsor: Cordis Corporation

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-10-04
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-10
• Primary Completion: 2008-03
• Study Completion: 2009-05
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Smart Stent	Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
2	Luminexx Stent	Bard® Luminexx™ 6F Vascular Stent

Primary Outcome Measures

Name	Time	Method
primary patency detectable by duplex ultrasound through the index lesion	12 months

Secondary Outcome Measures

Name	Time	Method
adverse events	baseline, discharge, 6 and 12 months post procedure
procedural success	up to removal of catheter sheath
binary restenosis	6 and 12 months
procedural complications	up to removal of catheter sheath
Ankle Brachial Index	discharge and 12 months
target lesion revascularisation	6 and 12 months
target vessel revascularisation	6 and 12 months
clinical categorization of chronic limb ischemia by means of the Rutherford classification	discharge, 6 and 12 months post procedure
technical success	time of deployment
stent fractures	6 and 12 months
primary patency	6 months

Trial Locations

Locations (2)

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, Germany