The Study to Treat Superficial Femoral Artery Occlusions. (SUPER UK)
June 2, 2009 updated by: Cordis Corporation
A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty Only for the Treatment of SUPERficial Femoral Artery Occlusions
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 binary restenosis at one year.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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 (5-22 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 and 6 months, and a 12 month clinical and duplex ultrasound assessment. This study will be conducted at up to 12 investigational sites.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Manchester, United Kingdom, M13 9WL
- Manchester Royal Infirmary
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Newcastle under Lyme, United Kingdom, ST4 6QG
- University Hospital of North Staffordshire
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- One superficial femoral artery de novo or restenotic lesion (> 70% stenosis or occlusions), with a lesion length > 5 to < 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. Additional intervention to further improve blood flow to the lower limb is acceptable during the index procedure, but after successful treatment of the study lesions
Exclusion Criteria:
- Revascularisation involving the same limb within 7 days prior to the index procedure or a planned revascularisation within 7 days after the index procedure Patient having total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow is allowed during the same procedure and prior to the treatment of the study lesion.
- Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of the Cordis medical monitor and the principal investigator of this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 2
balloon angioplasty
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balloon angioplasty
Other Names:
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Experimental: 1
Cordis SMART™ nitinol self-expanding stent.
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Cordis SMART™ nitinol self-expanding stent.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Binary restenosis as demonstrated by Duplex Ultrasound.
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Device success.
Time Frame: at time of deployment
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at time of deployment
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Procedural success: defined as successful recanalization, without the occurrence of a SAE event.
Time Frame: up to the moment the catheter sheath introducer has been removed
|
up to the moment the catheter sheath introducer has been removed
|
|
Ankle Brachial Index
Time Frame: at discharge and 12 months
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at discharge and 12 months
|
|
Restenosis measured by Duplex Ultrasound
Time Frame: at discharge and 12 months
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at discharge and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nick Chalmers, MD, Manchester Royal Infirmary
- Principal Investigator: Mark Cowling, MD, University Hospital of North Staffordshire
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
October 4, 2005
First Submitted That Met QC Criteria
October 4, 2005
First Posted (Estimate)
October 5, 2005
Study Record Updates
Last Update Posted (Estimate)
June 3, 2009
Last Update Submitted That Met QC Criteria
June 2, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EE04-01UK
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.