The Study to Treat Superficial Femoral Artery Occlusions. - Full Text View

Sponsor:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00232843

Purpose

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.

Condition	Intervention	Phase
Arterial Occlusive Diseases	Device: stent Device: angioplasty	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Clinical Investigation of the SMART™ Nitinol Self-Expandable Stent Versus Balloon Angioplasty Only for the Treatment of SUPERficial Femoral Artery Occlusions

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

U.S. FDA Resources

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

Binary restenosis as demonstrated by Duplex Ultrasound. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Device success. [ Time Frame: at time of deployment ] [ Designated as safety issue: No ]
Procedural success: defined as successful recanalization, without the occurrence of a SAE event. [ Time Frame: up to the moment the catheter sheath introducer has been removed ] [ Designated as safety issue: Yes ]
Ankle Brachial Index [ Time Frame: at discharge and 12 months ] [ Designated as safety issue: Yes ]
Restenosis measured by Duplex Ultrasound [ Time Frame: at discharge and 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	150
Study Start Date:	March 2005
Study Completion Date:	May 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cordis SMART™ nitinol self-expanding stent.	Device: stent Cordis SMART™ nitinol self-expanding stent.
2: Active Comparator balloon angioplasty	Device: angioplasty balloon angioplasty

Detailed Description:

This is a multi-center, prospective, randomized, two-arm study evaluating the performance of the Cordis SMART™ nitinol self-expanding stent as compared to angioplasty only.

It is anticipated that a total of 150 patients will be entered into the study. Patients will be randomized on a 1:1 basis of stent versus angioplasty only.

150 patients with de novo or restenotic native SFA occlusions (5-22 cm) with reference vessel of >= 4.0 to <= 6.0 mm in diameter will be randomized to the SMART™ nitinol self-expanding stent or to angioplasty only.

All patients will be followed for 12 months post-procedure, by telephone contact at 3 and 6 months, and a 12 month clinical and duplex ultrasound assessment. This study will be conducted at up to 12 investigational sites.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232843

Locations

United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
University Hospital of North Staffordshire
Newcastle under Lyme, United Kingdom, ST4 6QG

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:	Nick Chalmers, MD	Manchester Royal Infirmary
Principal Investigator:	Mark Cowling, MD	University Hospital of North Staffordshire

More Information

No publications provided

Responsible Party:	Cordis ( Dr. Hans-Peter Stoll )
Study ID Numbers:	EE04-01UK
Study First Received:	October 4, 2005
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00232843 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cordis Corporation:

Peripheral Artery Occlusive Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2009