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Sponsored by: |
Cordis Corporation |
Information provided by: | Cordis Corporation |
ClinicalTrials.gov Identifier: | NCT00232843 |
The main objective of this study is to assess the performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as determined by primary patency rate at one year.
Condition | Intervention | Phase |
Arterial Occlusive Diseases |
Device: stent Device: angioplasty |
Phase IV |
MedlinePlus related topics: | Angioplasty |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty Only for the Treatment of SUPERficial Femoral Artery Occlusions |
Estimated Enrollment: | 150 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Cordis SMART™ nitinol self-expanding stent.
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Device: stent
Cordis SMART™ nitinol self-expanding stent.
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2: Active Comparator
balloon angioplasty
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Device: angioplasty
balloon angioplasty
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This is a multi-center, prospective, randomized, two-arm study evaluating the performance of the Cordis SMART™ nitinol self-expanding stent as compared to angioplasty only.
It is anticipated that a total of 150 patients will be entered into the study. Patients will be randomized on a 1:1 basis of stent versus angioplasty only.
150 patients with de novo or restenotic native SFA occlusions (5-14.5 cm) with reference vessel of >= 4.0 to <= 6.0 mm in diameter will be randomized to the SMART™ nitinol self-expanding stent or to angioplasty only.
All patients will be followed for 12 months post-procedure, by telephone contact at 3, 6, 9 months and a 12 month clinical and duplex ultrasound assessment. This study will be conducted at up to 12 investigational sites.
Ages Eligible for Study: | 30 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |||||
Manchester Royal Infirmary | |||||
Manchester, United Kingdom, M13 9WL | |||||
University Hospital of North Staffordshire | |||||
Newcastle under Lyme, United Kingdom, ST4 6QG |
Cordis Corporation |
Principal Investigator: | Nick Chalmers, MD | Manchester Royal Infirmary |
Principal Investigator: | Mark Cowling, MD | University Hospital of North Staffordshire |
Responsible Party: | Cordis ( Dr. Hans-Peter Stoll ) |
Study ID Numbers: | EE04-01UK |
First Received: | October 4, 2005 |
Last Updated: | August 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00232843 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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