The Study to Treat Superficial Femoral Artery Occlusions.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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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 (5-22 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.

Conditions

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Arterial Occlusive Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Cordis SMART™ nitinol self-expanding stent.

Group Type EXPERIMENTAL

stent

Intervention Type DEVICE

Cordis SMART™ nitinol self-expanding stent.

2

balloon angioplasty

Group Type ACTIVE_COMPARATOR

angioplasty

Intervention Type DEVICE

balloon angioplasty

Interventions

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stent

Cordis SMART™ nitinol self-expanding stent.

Intervention Type DEVICE

angioplasty

balloon angioplasty

Intervention Type DEVICE

Other Intervention Names

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Cordis SMART™ nitinol self-expanding stent balloon angioplasty

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No