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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00232843
First received: October 4, 2005
Last updated: June 2, 2009
Last verified: June 2009

October 4, 2005
June 2, 2009
March 2005
April 2009   (final data collection date for primary outcome measure)
Binary restenosis as demonstrated by Duplex Ultrasound. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The primary endpoint will be primary patency at one year as demonstrated by Duplex Ultrasound
Complete list of historical versions of study NCT00232843 on ClinicalTrials.gov Archive Site
  • Device success. [ Time Frame: at time of deployment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Ankle Brachial Index [ Time Frame: at discharge and 12 months ] [ Designated as safety issue: Yes ]
  • Restenosis measured by Duplex Ultrasound [ Time Frame: at discharge and 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
The Study to Treat Superficial Femoral Artery Occlusions.
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Arterial Occlusive Diseases
  • Device: stent
    Cordis SMART™ nitinol self-expanding stent.
    Other Name: Cordis SMART™ nitinol self-expanding stent
  • Device: angioplasty
    balloon angioplasty
    Other Name: balloon angioplasty
  • Experimental: 1
    Cordis SMART™ nitinol self-expanding stent.
    Intervention: Device: stent
  • Active Comparator: 2
    balloon angioplasty
    Intervention: Device: angioplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
May 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00232843
EE04-01UK
Yes
Dr. Hans-Peter Stoll, Cordis
Cordis Corporation
Not Provided
Principal Investigator: Nick Chalmers, MD Manchester Royal Infirmary
Principal Investigator: Mark Cowling, MD University Hospital of North Staffordshire
Cordis Corporation
June 2009

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