Arterial Occlusive Diseases
Conditions
Keywords
Peripheral Artery Occlusive Disease
Brief summary
The main objective of this study is to assess the patency rate of the nitinol self-expandable stent device in the treatment of superficial femoral artery (SFA) occlusions as compared to angioplasty only.
Detailed description
This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ nitinol self-expanding stent as compared to balloon angioplasty only. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study. The study population will consist of symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, long de novo or restenotic occlusions (5 - 14.5 cm) on diagnostic imaging with a history of at least 6 months. The occlusions must not extend beyond the proximal popliteal artery. For the purpose of this protocol, no lesion within 3 cm of the upper part of the patella may be treated. The distal popliteal artery must be patent with no hemodynamic stenosis as well as two calf vessels. Reference vessel diameter must be \>= 4.0 to \<= 6.0 mm. Trial participants will be randomized to the SMART™ nitinol self-expanding stent or to balloon angioplasty only. 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 at 8 investigational sites in The Netherlands.
Interventions
DEVICEstent
Cordis SMART™ Nitinol Stent
DEVICEangioplasty
balloon angioplasty
Sponsors
Cordis US Corp.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. The patient should be suitable for percutaneous transluminal angioplasty (PTA) and also for stenting.
Exclusion criteria
1. Poor aortoiliac or common femoral inflow, which would be deemed inadequate to support a femoropopliteal bypass graft. 2. Patient having total occlusions or severe stenosis of the iliac artery on the same side must be excluded. 3. Gangrene in index limb (Rutherford category 6).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Technical success defined as a successful access and deployment of the device with recanalization, determined by angiography. | at deployment |
| Procedural success defined as successful recanalization, without the occurrence of a SAE. | up to the moment haemostasis has been achieved |
| Procedural complications, defined as any adverse event | from start of the procedure up to the moment haemostasis has been achieved |
| Quality of Life assessment. | baseline, 6, and 12 months post procedure |
| Treadmill test. | 12 months |
| Restenosis measured by Duplex Ultrasound. | 12 months |
| Ankle Brachial Index. | discharge and 12 months |
Countries
Netherlands
Outcome results
None listed