The Study to Compare the Treatment of Angioplasty and Stents in SFA 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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-06-30

Brief Summary

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The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.

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Detailed Description

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This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study.

The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be \>= 4.0 to \<= 6.0 mm.

Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only.

Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure.

This study will be conducted at 8 investigational sites in The Netherlands.

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 Stent

Group Type EXPERIMENTAL

stent

Intervention Type DEVICE

Cordis SMART™ Nitinol Stent

2

balloon angioplasty

Group Type ACTIVE_COMPARATOR

angioplasty

Intervention Type DEVICE

balloon angioplasty

Interventions

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stent

Cordis SMART™ Nitinol Stent

Intervention Type DEVICE

angioplasty

balloon angioplasty

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months
2. The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.

Exclusion Criteria

1. Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
2. Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded.
3. Gangrene in index limb (Rutherford category 6).

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No