The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00235131

Purpose

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	Intervention	Phase
Arterial Occlusive Diseases	Device: Smart Stent Device: Luminexx Stent	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

primary patency detectable by duplex ultrasound through the index lesion [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

technical success [ Time Frame: time of deployment ] [ Designated as safety issue: No ]
procedural success [ Time Frame: up to removal of catheter sheath ] [ Designated as safety issue: No ]
procedural complications [ Time Frame: up to removal of catheter sheath ] [ Designated as safety issue: Yes ]
Ankle Brachial Index [ Time Frame: discharge and 12 months ] [ Designated as safety issue: Yes ]
primary patency [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
binary restenosis [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
stent fractures [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
target lesion revascularisation [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
target vessel revascularisation [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
adverse events [ Time Frame: baseline, discharge, 6 and 12 months post procedure ] [ Designated as safety issue: Yes ]
clinical categorization of chronic limb ischemia by means of the Rutherford classification [ Time Frame: discharge, 6 and 12 months post procedure ] [ Designated as safety issue: Yes ]

Enrollment:	200
Study Start Date:	May 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System	Device: Smart Stent Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
2: Active Comparator Bard® Luminexx™ 6F Vascular Stent	Device: Luminexx Stent Bard® Luminexx™ 6F Vascular 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235131

Locations

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

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:	Dierk Schneinert, MD	Herzzentrum Leipzig
Principal Investigator:	Stephan Duda, MD	Gemeinschaftspraxis füsar Radiologische

More Information

Responsible Party:	Cordis ( Dr. Hans-Peter Stoll )
Study ID Numbers:	EE04-02
Study First Received:	October 4, 2005
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00235131
Health Authority:	Germany: Ethics Commission

Keywords provided by Cordis Corporation:

Peripheral Artery Occlusive Disease

Study placed in the following topic categories:

Arterial Occlusive Diseases
Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009