The Study to Compare SMART Nitinol Stent and Balloon Angioplasty

NCT00309595 | Completed Phase 4 DMC

• 1 other identifier: EE04-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Superficial Femoral Artery Occlusions

Outcome Measures

Primary Outcomes (1)

• Binary restenosis by Duplex Ultrasound.

  1 year

Secondary Outcomes (14)

• Technical success defined as a successful access and deployment of the device with recanalization.

  at the time of deployment

• Procedural complications.

  up to the moment the catheter sheath introducer has been removed

• Procedural success as defined by successful recanalization, without the occurence of a Serious Adverse Event (SAE).

  up to the catheter sheath introducer has been removed

• Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital.

  1, 6 and 12 months

• Ankle Brachial Index (ABI).

  discharge, 1, 6 and 12 months

Study Arms (2)

1

EXPERIMENTAL

Cordis SMART™ nitinol self expandable stent

Device: stent

2

ACTIVE COMPARATOR

balloon

Device: balloon

Interventions

stent DEVICE

Cordis SMART™ Nitinol Stent System

1

balloon DEVICE

balloon angioplasty

2

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (2)

Univeristy Hospital Bern

Bern, CH-3010, Switzerland

Location

University Hospital Zurich

Zurich, CH-8091, Switzerland

Location

MeSH Terms

Interventions

Stents

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Iris Baumgartner, MD

  Leitende Aerztin & Leiterin Vaskuläre Forschung - University Hospital Bern

  PRINCIPAL INVESTIGATOR

• Beatrice Amann, MD

  Leitende Ärztin Angiologie - University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 3, 2006
• Study Start: December 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 12, 2009

Record last verified: 2009-06

Locations

CH (2)