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The Study to Treat Superficial Femoral Artery Occlusions. (SUPER UK)

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.
 
ClinicalTrials.gov Identifier: NCT00232843
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
Cordis Corporation

Tracking Information
First Submitted Date  ICMJE October 4, 2005
First Posted Date  ICMJE October 5, 2005
Last Update Posted Date June 3, 2009
Study Start Date  ICMJE March 2005
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
Binary restenosis as demonstrated by Duplex Ultrasound. [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2005)
The primary endpoint will be primary patency at one year as demonstrated by Duplex Ultrasound
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2009)
  • Device success. [ Time Frame: at time of deployment ]
  • 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 ]
  • Ankle Brachial Index [ Time Frame: at discharge and 12 months ]
  • Restenosis measured by Duplex Ultrasound [ Time Frame: at discharge and 12 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study to Treat Superficial Femoral Artery Occlusions.
Official Title  ICMJE A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty Only for the Treatment of SUPERficial Femoral Artery Occlusions
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arterial Occlusive Diseases
Intervention  ICMJE
  • Device: stent
    Cordis SMART™ nitinol self-expanding stent.
    Other Name: Cordis SMART™ nitinol self-expanding stent
  • Device: angioplasty
    balloon angioplasty
    Other Name: balloon angioplasty
Study Arms  ICMJE
  • Experimental: 1
    Cordis SMART™ nitinol self-expanding stent.
    Intervention: Device: stent
  • Active Comparator: 2
    balloon angioplasty
    Intervention: Device: angioplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2005)
150
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00232843
Other Study ID Numbers  ICMJE EE04-01UK
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Hans-Peter Stoll, Cordis
Study Sponsor  ICMJE Cordis Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nick Chalmers, MD Manchester Royal Infirmary
Principal Investigator: Mark Cowling, MD University Hospital of North Staffordshire
PRS Account Cordis Corporation
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP