The Study to Compare SMART Nitinol Stent and Balloon Angioplasty

Study Overview
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Brief Summary
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This is a multi-center prospective, randomized, two-arm study evaluating performance of the Cordis SMART™ Nitinol Stent System compared to balloon angioplasty. Patients will be randomized on a 1:1 basis. It is anticipated that a total of 120 patients will be entered into the study. Objective of the study is: Performance of the Cordis S.M.A.R.T.™ (CONTROL™) Nitinol Stent System for the treatment of superficial femoral artery (SFA) long de novo or restenotic lesions (≥ 70% stenosis or occlusions) in comparison with balloon angioplasty as determined by Binary Restenosis (≥50% restenosis based on a peak systolic velocity ratio ≥ 2.5) at one year as demonstrated by Duplex sonography.

Detailed Description
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The study population will consist of 120 symptomatic peripheral vascular disease patients with SFA occlusions. The disease will consist of symptomatic, de novo or restenotic occlusions (5 - 22 cm) on diagnostic imaging. 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. At least one calf vessel must be patent. Reference vessel diameter must be >= 4.0 to <= 6.0 mm. Trial participants who meet all entry criteria, will be randomized to the SMART™ Nitinol Stent or balloon angioplasty. Patients will be followed for 12 months after the procedure. Study examinations will be done at screening, procedure time, discharge, 1, 6 and 12 months after the study procedure. This study will be conducted as an investigator initiated multicenter study with 6 study centers in Switzerland. Principal investigators will be Prof. Amann, PD Dr. med T. Pfammatter (University Hospital Zürich) and Prof. I. Baumgartner, Prof. J. Triller (University Hospital Bern).

Official Title
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A Multi-Center Prospective, Randomized, Two-Arm Clinical Investigation of the Cordis SMARTTM Nitinol Self Expandable Stent Versus Balloon Angioplasty Only for the Treatment of Superficial Femoral Artery Occlusions.

Conditions
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Superficial Femoral Artery Occlusions

Intervention / Treatment
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* Device: stent
* Device: balloon


Participation Criteria
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Eligibility Criteria
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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 3 months; One de-novo or restenotic SFA with an occluded length > 5 to < 22 cm; Patent popliteal artery on the index side (without > 50% stenotic (re) stenotic lesions) and at least single vessel infrapopliteal runoff (without > 50% stenotic (re) stenotic lesions). However, balloon angioplasty to further improve the blood flow is allowed at the index procedure. Exclusion Criteria: Revascularization involving the same limb 30 days prior to the index procedure or a planned revascularization within 30 days after the index procedure; Patients having severe stenoses or total occlusions of the iliac artery on the same side must be excluded. However, intervention to restore adequate blood flow during the index procedure (prior to the treatment of the target lesion) is allowed; Requiring stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Cordis SMART™ nitinol self expandable stent | Device: stent<br>* Cordis SMART™ Nitinol Stent System<br>|
| Active Comparator: 2<br>balloon | Device: balloon<br>* balloon angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary restenosis by Duplex Ultrasound. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success defined as a successful access and deployment of the device with recanalization. |  | at the time of deployment | 
| Procedural complications. |  | up to the moment the catheter sheath introducer has been removed | 
| Procedural success as defined by successful recanalization, without the occurence of a Serious Adverse Event (SAE). |  | up to the catheter sheath introducer has been removed | 
| Occurrence of Adverse events (AE) and Serious Adverse Events (SAE) in-hospital. |  | 1, 6 and 12 months | 
| Ankle Brachial Index (ABI). |  | discharge, 1, 6 and 12 months | 
| Restenosis measured by Duplex sonography. |  | 1, 6 and 12 months | 
| Target Lesion revascularisation (TLR). |  | 1 year | 
| Target Vessel revascularisation (TVR). |  | 1 year | 
| Target Limb revascularisation. |  | 1 year | 
| The number of revascularisations in both limbs. |  | 1 year | 
| Clinical categorization of chronic limb ischemia by means of the Rutherford classification. |  | 1, 6 and 12 months | 
| Pain free and absolute walking distance (treadmill testing) as compared to baseline testing. |  | 1 and 12 months post index procedure | 
| Amputation of the index limb. |  | 1 year | 
| Cardiovascular events (ACS, TIA, stroke, vascular death). |  | 1 year |