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Tracking Information | |||||||||
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First Received Date † | October 4, 2005 | ||||||||
Last Updated Date | March 16, 2009 | ||||||||
Start Date † | May 2005 | ||||||||
Current Primary Outcome Measures † |
primary patency detectable by duplex ultrasound through the index lesion [ Time Frame: 12 months ] [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00235131 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent | ||||||||
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 | ||||||||
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. |
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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 Phase | Phase IV | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
Condition † | Arterial Occlusive Diseases | ||||||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Active, not recruiting | ||||||||
Enrollment † | 200 | ||||||||
Estimated Completion Date | March 2009 | ||||||||
Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years to 80 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | Germany | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00235131 | ||||||||
Responsible Party | Dr. Hans-Peter Stoll, Cordis | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Cordis Corporation | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | Cordis Corporation | ||||||||
Verification Date | March 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |