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

Primary Purpose

Arterial Occlusive Diseases

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
stent
angioplasty
Sponsored by
Cordis Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring Peripheral Artery Occlusive Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Manchester Royal Infirmary
  • University Hospital of North Staffordshire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Cordis SMART™ nitinol self-expanding stent.

balloon angioplasty

Outcomes

Primary Outcome Measures

Binary restenosis as demonstrated by Duplex Ultrasound.

Secondary Outcome Measures

Device success.
Procedural success: defined as successful recanalization, without the occurrence of a SAE event.
Ankle Brachial Index
Restenosis measured by Duplex Ultrasound

Full Information

First Posted
October 4, 2005
Last Updated
June 2, 2009
Sponsor
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00232843
Brief Title
The Study to Treat Superficial Femoral Artery Occlusions.
Acronym
SUPER UK
Official Title
A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty Only for the Treatment of SUPERficial Femoral Artery Occlusions
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cordis Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Diseases
Keywords
Peripheral Artery Occlusive Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Cordis SMART™ nitinol self-expanding stent.
Arm Title
2
Arm Type
Active Comparator
Arm Description
balloon angioplasty
Intervention Type
Device
Intervention Name(s)
stent
Other Intervention Name(s)
Cordis SMART™ nitinol self-expanding stent
Intervention Description
Cordis SMART™ nitinol self-expanding stent.
Intervention Type
Device
Intervention Name(s)
angioplasty
Other Intervention Name(s)
balloon angioplasty
Intervention Description
balloon angioplasty
Primary Outcome Measure Information:
Title
Binary restenosis as demonstrated by Duplex Ultrasound.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Device success.
Time Frame
at time of deployment
Title
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
Title
Ankle Brachial Index
Time Frame
at discharge and 12 months
Title
Restenosis measured by Duplex Ultrasound
Time Frame
at discharge and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Chalmers, MD
Organizational Affiliation
Manchester Royal Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Cowling, MD
Organizational Affiliation
University Hospital of North Staffordshire
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manchester Royal Infirmary
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
University Hospital of North Staffordshire
City
Newcastle under Lyme
ZIP/Postal Code
ST4 6QG
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

The Study to Treat Superficial Femoral Artery Occlusions.

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