The Study to Compare SMART Nitinol Stent and Balloon Angioplasty

NCT ID: NCT00309595

Last Updated: 2009-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2009-05-31

Brief Summary

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

Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent System for the treatment of superficial femoral artery (SFA) long de novo or restenotic lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one year as demonstrated by Duplex sonography.

Detailed Description

The study population will consist of 120 symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, de novo or restenotic occlusions (5 - 22 cm) on diagnostic imaging. 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. At least one calf vessel must be patent. Reference vessel diameter must be >= 4.0 to <= 6.0 mm.

Trial participants who meet all entry criteria, will be randomized to the SMART™ Nitinol Stent or balloon angioplasty.

Patients will be followed for 12 months after the procedure. Study examinations will be done at screening, procedure time, discharge, 1, 6 and 12 months after the study procedure.

This study will be conducted as an investigator initiated multicenter study with 6 study centers in Switzerland. Principal investigators will be Prof. Amann, PD Dr. med T. Pfammatter (University Hospital Zürich) and Prof. I. Baumgartner, Prof. J. Triller (University Hospital Bern).

Conditions

Superficial Femoral Artery Occlusions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Cordis SMART™ nitinol self expandable stent

Group Type: EXPERIMENTAL

stent

Intervention Type: DEVICE

Cordis SMART™ Nitinol Stent System

2

balloon

Group Type: ACTIVE_COMPARATOR

balloon

Intervention Type: DEVICE

balloon angioplasty

Interventions

stent

Cordis SMART™ Nitinol Stent System

Intervention Type: DEVICE

balloon

balloon angioplasty

Intervention Type: DEVICE

Eligibility Criteria

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 3 months;

2. One de-novo or restenotic SFA with an occluded length > 5 to < 22 cm;

3. Patent popliteal artery on the index side (without > 50% stenotic (re) stenotic lesions) and at least single vessel infrapopliteal runoff (without > 50% stenotic (re) stenotic lesions). However, balloon angioplasty to further improve the blood flow is allowed at the index procedure.

Exclusion Criteria

1. Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure;

2. Patients having severe stenoses or total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow during the index procedure (prior to the treatment of the target lesion) is allowed;

3. Requiring stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cordis Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Cordis

Principal Investigators

Iris Baumgartner, MD

Role: PRINCIPAL_INVESTIGATOR

Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital Bern

Beatrice Amann, MD

Role: PRINCIPAL_INVESTIGATOR

Leitende Ärztin Angiologie - University Hospital Zurich

Locations

Univeristy Hospital Bern

Bern, , Switzerland

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

EE04-03

Identifier Type: -

Identifier Source: org_study_id