Arterial Occlusive Diseases
Conditions
Keywords
Peripheral Artery Occlusive Disease
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.
Detailed description
This is a German multi-center prospective, randomized, two-arm study evaluating performance of the Cordis S.M.A.R.T.™ CONTROL ™ Nitinol Stent System as compared to the C.R. Bard® Luminexx™ 6F Vascular Stent. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 200 patients will be entered into the study. The study population will consist of approximately 200 symptomatic peripheral vascular disease patients with TASC C & D SFA lesions. The disease will consist of symptomatic, long de novo or restenotic lesions (\> 70% stenosis) and occlusions (5 - 22 cm) on diagnostic imaging. The lesion must not extend into the distal SFA and the popliteal artery. At least one distal popliteal artery must be patent as well as one calf vessel. Reference vessel diameter must be \>= 4.0 to \<= 6.0 mm. Trial participants will be randomized to the Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System or to the Bard® Luminexx™ 6F Vascular Stent. Patients will be followed for twelve months post-procedure. Study examinations will be done at screening, procedure time, discharge, six, and twelve months post procedure. This study will be conducted over up to 15 investigational sites in Germany.
Interventions
DEVICESmart Stent
Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System
DEVICELuminexx Stent
Bard® Luminexx™ 6F Vascular Stent
Sponsors
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| primary patency detectable by duplex ultrasound through the index lesion | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| binary restenosis | 6 and 12 months |
| technical success | time of deployment |
| target lesion revascularisation | 6 and 12 months |
| target vessel revascularisation | 6 and 12 months |
| adverse events | baseline, discharge, 6 and 12 months post procedure |
| clinical categorization of chronic limb ischemia by means of the Rutherford classification | discharge, 6 and 12 months post procedure |
| stent fractures | 6 and 12 months |
Countries
Germany
Outcome results
None listed