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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Cordis SMART™ nitinol self-expanding stent.
balloon angioplasty
Manchester Royal Infirmary
Manchester, United Kingdom
University Hospital of North Staffordshire
Newcastle-under-Lyme, United Kingdom
Binary restenosis as demonstrated by Duplex Ultrasound.
Time frame: 1 year
Device success.
Time frame: at time of deployment
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
Ankle Brachial Index
Time frame: at discharge and 12 months
Restenosis measured by Duplex Ultrasound
Time frame: at discharge and 12 months
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