The Study to Compare the Cordis SMART™ Stent System With the Bard® Luminexx™ Stent

NCT00235131 | Completed Phase 4 DMC

• 1 other identifier: EE04-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

This study will look at the performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System for the treatment of TASC C \& D superficial femoral artery long lesions (up to 22 cm) in comparison with the Bard® Luminexx™ 6F Vascular Stent as determined by the primary patency rate at 6 and 12 months post procedure.

Conditions

Arterial Occlusive Diseases

Keywords

Peripheral Artery Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• primary patency detectable by duplex ultrasound through the index lesion

  12 months

Secondary Outcomes (11)

• technical success

  time of deployment

• procedural success

  up to removal of catheter sheath

• procedural complications

  up to removal of catheter sheath

• Ankle Brachial Index

  discharge and 12 months

• primary patency

  6 months

Study Arms (2)

1

EXPERIMENTAL

Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System

Device: Smart Stent

2

ACTIVE COMPARATOR

Bard® Luminexx™ 6F Vascular Stent

Device: Luminexx Stent

Interventions

Smart Stent DEVICE

Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System

1

Luminexx Stent DEVICE

Bard® Luminexx™ 6F Vascular Stent

2

Eligibility Criteria

• Age: 18 Years - 80 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 2, 3, 4 or 5); duration of intermittent claudication (category 2-3) should be at least 3 months.
• One superficial femoral artery de novo or restenotic lesion (more than 70% stenosis or occlusions), with a lesion length of more than 5 to less than 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.

You may not qualify if:

• Revascularisation involving the same limb within 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure.
• Patients having total occlusions of the iliac artery on the same side must be excluded.
• Previously implanted stent(s) in the to be treated artery at the same site.
• Requiring stent placement in the distal superficial femoral artery and the popliteal artery.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (2)

Gemeinschaftspraxis füsar Radiologische Diagnostik& Zentrum für Minimal Invasite Therapie am Jüdischen Krankenhaus Berlin

Berlin, 13347, Germany

Location

Universitat Leipzig Herzzentrum Abt. Für Klinische u. Intervent. Angiologie

Leipzig, 04289, Germany

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dierk Schneinert, MD

  Heart Center Leipzig - University Hospital

  PRINCIPAL INVESTIGATOR

• Stephan Duda, MD

  Gemeinschaftspraxis füsar Radiologische

  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: October 4, 2005
• First Posted: October 10, 2005
• Study Start: May 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: May 1, 2009
• Last Updated: February 4, 2010

Record last verified: 2010-02

Locations

DE (2)