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

Phase 4TerminatedNCT00289055

Cordis US Corp.10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Arterial Occlusive Diseases

Interventions

stentDEVICE

Cordis SMART™ Nitinol Stent

angioplastyDEVICE

balloon angioplasty

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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).

Locations (1)

AMC

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Primary patency.

Time frame: 12 months

Secondary Outcomes

Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography.

Time frame: at deployment

Procedural success defined as successful recanalization, without the occurrence of a SAE.

Time frame: up to the moment haemostasis has been achieved

Procedural complications, defined as any adverse event

Time frame: from start of the procedure up to the moment haemostasis has been achieved

Ankle Brachial Index.

Time frame: discharge and 12 months

Treadmill test.

Time frame: 12 months

Restenosis measured by Duplex Ultrasound.

Time frame: 12 months

Quality of Life assessment.

Time frame: baseline, 6, and 12 months post procedure

Data from ClinicalTrials.gov

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