A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease

Study Overview
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Brief Summary
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The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA (balloon angioplasty). If SM-01 is used in a PTA-bailout patient, the case will be assessed separately.

Official Title
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A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: SM-01
* Device: PTA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 20 years. Symptomatic leg ischemia by Rutherford Classification (category1, 2, or 3). Lesion length >= 40 mm to <= 150 mm. (must be treatable with no more than two SM-01 stents. Overlap should be about 1cm if two stents are used) Reference vessel diameter (RVD) >= 4.0 mm and <= 7.0 mm. All lesions are to be located >= 3.0 cm proximal to the superior edge of the patella, and >= 1.0 cm distal to the SFA / PFA bifurcation. >= 50% stenosis or total occlusion. Patent infrapopliteal and popliteal arteries, i.e., single-vessel runoff or better with at least one of three vessels patent (< 50% stenosis) to the ankle or foot. Patient or legally authorized representative must provide written informed consent prior to initiation of study procedures. A patient with bilateral obstructive SFA disease is eligible for enrollment into the study. If a patient with bilateral disease is enrolled, the target limb will be the more severe limb. The more severe limb will be selected according to clinical symptomatology. If clinical symptomatology is similar, the more clinically severe lesion will be selected. The contralateral procedure should not be done until at least 30 days after the index procedure of the more severe limb was attempted. Exclusion Criteria: Recent hemorrhagic disease within the past 3 months. Aneurysm in the SFA or popliteal artery. Acute limb occlusion. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as severe calcification which is resistant to stenting, or for in-stent restenosis. Poor iliac or common femoral inflow.(However, intervention to restore adequate blood flow prior to the treatment of the study lesion is allowed.) Known allergies to aspirin, heparin, or ticlopidine, or bleeding diathesis. Patients unable or unwilling to tolerate anticoagulant or antiplatelet therapy. Patients unable or unwilling to tolerate contrast agents used in intravascular procedures. Allergic to nitinol or tantalum. Women who are pregnant or lactating, or of child bearing potential, or with a desire to be a parent during the study period. Significant vessel tortuosity or other parameters prohibiting access to the lesion or which would prevent delivery of the stent device. Revascularization involving the same limb 30 days prior to the index procedure or a planned re-vascularization within 30 days after the index procedure. Previously implanted stent(s) at the same site in the artery to be treated. Requiring stent placement in the distal SFA or popliteal artery. Presence of a femoral artificial graft. History of participating in any other clinical study within 1 year. Life expectancy less than 3 years, or any other factors preventing clinical follow-up. Receiving dialysis or immunosuppressant therapy Serum creatinine level >= 2.0 mg/dL before procedure. A principal investigator or a co-principal investigator determines that patient is unsuitable for this study.

Ages Eligible for Study
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Minimum Age: 20 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: SM-01<br> | Device: SM-01<br>* SM-01 is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.<br>|
| Active Comparator: PTA<br> | Device: PTA<br>* balloon angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-TVF(Target-vessel failure) rate | The primary endpoint will be freedom from TVF defined as any events of clinical driven (confirmed by duplex ultrasound or angiography) TLR/TVR, procedure failure, amputation of the target lesion's leg, procedure or device related death, occlusion of target lesion, or > 70% restenosis of target lesion. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success rate |  | 12 Months | 
| Procedure Success rate for Bailout |  | 12 Months | 
| Difference between pre and post proceduer of ABI |  | 12 Months | 
| Difference between pre and post procedure of Rutherford Categories |  | 12 Months | 
| Non-TLR/TVR rate |  | 12 Months | 
| Primary Patency rate |  | 12 Months | 
| Stent Fracture rate |  | 12 Months | 
| Difference between pre and post procedure of QOL (SF-36) |  | 12 Months | 
| Major Clinical Event rate |  | 12 Months |