The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent (SUPER SL)

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

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.

Study Overview

• Status: Completed
• Conditions: Arterial Occlusive Diseases
• Intervention / Treatment: Device: Smart Stent; Device: Luminexx Stent

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13347
    • Gemeinschaftspraxis füsar Radiologische Diagnostik& Zentrum für Minimal Invasite Therapie am Jüdischen Krankenhaus Berlin
  • Leipzig, Germany, 04289
    • Universitat Leipzig Herzzentrum Abt. Für Klinische u. Intervent. Angiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System	Device: Smart Stent; Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
Active Comparator: 2; Bard® Luminexx™ 6F Vascular Stent	Device: Luminexx Stent; Bard® Luminexx™ 6F Vascular Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
primary patency detectable by duplex ultrasound through the index lesion	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cordis Corporation
• Investigators: Principal Investigator: Dierk Schneinert, MD, Heart Center Leipzig - University Hospital; Principal Investigator: Stephan Duda, MD, Gemeinschaftspraxis füsar Radiologische

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: October 4, 2005
• First Submitted That Met QC Criteria: October 7, 2005
• First Posted (Estimate): October 10, 2005

Study Record Updates

• Last Update Posted (Estimate): February 4, 2010
• Last Update Submitted That Met QC Criteria: February 3, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Peripheral Artery Occlusive Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: EE04-02