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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00235131
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : February 4, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Device: Smart Stent Device: Luminexx Stent Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2005
Actual Primary Completion Date : March 2008
Actual Study Completion Date : May 2009

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

Primary Outcome Measures :
  1. primary patency detectable by duplex ultrasound through the index lesion [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. technical success [ Time Frame: time of deployment ]
  2. procedural success [ Time Frame: up to removal of catheter sheath ]
  3. procedural complications [ Time Frame: up to removal of catheter sheath ]
  4. Ankle Brachial Index [ Time Frame: discharge and 12 months ]
  5. primary patency [ Time Frame: 6 months ]
  6. binary restenosis [ Time Frame: 6 and 12 months ]
  7. stent fractures [ Time Frame: 6 and 12 months ]
  8. target lesion revascularisation [ Time Frame: 6 and 12 months ]
  9. target vessel revascularisation [ Time Frame: 6 and 12 months ]
  10. adverse events [ Time Frame: baseline, discharge, 6 and 12 months post procedure ]
  11. clinical categorization of chronic limb ischemia by means of the Rutherford classification [ Time Frame: discharge, 6 and 12 months post procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00235131

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Gemeinschaftspraxis füsar Radiologische Diagnostik& Zentrum für Minimal Invasite Therapie am Jüdischen Krankenhaus Berlin
Berlin, Germany, 13347
Universitat Leipzig Herzzentrum Abt. Für Klinische u. Intervent. Angiologie
Leipzig, Germany, 04289
Sponsors and Collaborators
Cordis Corporation
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Principal Investigator: Dierk Schneinert, MD Heart Center Leipzig - University Hospital
Principal Investigator: Stephan Duda, MD Gemeinschaftspraxis füsar Radiologische

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Responsible Party: Dr. Hans-Peter Stoll, Cordis Identifier: NCT00235131    
Other Study ID Numbers: EE04-02
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010
Keywords provided by Cordis Corporation:
Peripheral Artery Occlusive Disease
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases