The Study to Treat Superficial Femoral Artery Occlusions.

NCT00232843 | Completed Phase 4 DMC

• 1 other identifier: EE04-01UK
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this study is to assess the performance of the Cordis SMART™ nitinol self-expandable stent for the treatment of superficial femoral artery (SFA) occlusions in comparison with balloon angioplasty only as determined by binary restenosis at one year.

Conditions

Arterial Occlusive Diseases

Keywords

Peripheral Artery Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• Binary restenosis as demonstrated by Duplex Ultrasound.

  1 year

Secondary Outcomes (4)

• Device success.

  at time of deployment

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

  up to the moment the catheter sheath introducer has been removed

• Ankle Brachial Index

  at discharge and 12 months

• Restenosis measured by Duplex Ultrasound

  at discharge and 12 months

Study Arms (2)

1

EXPERIMENTAL

Cordis SMART™ nitinol self-expanding stent.

Device: stent

2

ACTIVE COMPARATOR

balloon angioplasty

Device: angioplasty

Interventions

stent DEVICE

Cordis SMART™ nitinol self-expanding stent.

Also known as: Cordis SMART™ nitinol self-expanding stent

1

angioplasty DEVICE

balloon angioplasty

Also known as: 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:

• One superficial femoral artery de novo or restenotic lesion (\> 70% stenosis or occlusions), with a lesion length \> 5 to \< 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. Additional intervention to further improve blood flow to the lower limb is acceptable during the index procedure, but after successful treatment of the study lesions

You may not qualify if:

• Revascularisation involving the same limb within 7 days prior to the index procedure or a planned revascularisation within 7 days after the index procedure Patient having total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow is allowed during the same procedure and prior to the treatment of the study lesion.
• Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of the Cordis medical monitor and the principal investigator of this study.

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (2)

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

University Hospital of North Staffordshire

Newcastle-under-Lyme, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Peripheral Arterial Occlusive Disease 1

Interventions

Stents; Angioplasty; Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Nick Chalmers, MD

  Manchester Royal Infirmary

  PRINCIPAL INVESTIGATOR

• Mark Cowling, MD

  University Hospital of North Staffordshire

  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 5, 2005
• Study Start: March 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: June 3, 2009

Record last verified: 2009-06

Locations

GB (2)