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

NCT ID: NCT00235131

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2009-05-31

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.

Conditions

Arterial Occlusive Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System

Group Type: EXPERIMENTAL

Smart Stent

Intervention Type: DEVICE

Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System

2

Bard® Luminexx™ 6F Vascular Stent

Group Type: ACTIVE_COMPARATOR

Luminexx Stent

Intervention Type: DEVICE

Bard® Luminexx™ 6F Vascular Stent

Interventions

Smart Stent

Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System

Intervention Type: DEVICE

Luminexx Stent

Bard® Luminexx™ 6F Vascular Stent

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Cordis

Principal Investigators

Dierk Schneinert, MD

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Stephan Duda, MD

Role: PRINCIPAL_INVESTIGATOR

Gemeinschaftspraxis füsar Radiologische

Locations

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

Countries

Germany

Other Identifiers

EE04-02

Identifier Type: -

Identifier Source: org_study_id