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

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 primary patency rate at one year.

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

MedlinePlus related topics:

Angioplasty

U.S. FDA Resources

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

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

Primary patency 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 ]
Quality of Life assessment. [ Time Frame: at baseline, 3, 6, 9 and 12 months post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	March 2005
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	August 2008 (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 (5-14.5 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, 6, 9 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:

Symptomatic leg ischemia by Rutherford classification (category 1, 2, 3, 4 or 5); duration of intermittent claudication (category 1-3) should be at least 6 months.
One superficial femoral artery occlusion or re-occlusion with an occluded length > 5 to < 14.5 cm.

Exclusion Criteria:

Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft.
Patient having total occlusions of the iliac artery on the same side must be excluded.

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

Responsible Party:	Cordis ( Dr. Hans-Peter Stoll )
Study ID Numbers:	EE04-01UK
First Received:	October 4, 2005
Last Updated:	August 11, 2008
ClinicalTrials.gov Identifier:	NCT00232843
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cordis Corporation:

Peripheral Artery Occlusive Disease

Study placed in the following topic categories:

Arterial Occlusive Diseases

Vascular Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 15, 2008

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