S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease

Study Overview
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Brief Summary
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A multi-center, non-randomized, single-arm, prospective trial evaluating the safety and effectiveness of the S.M.A.R.T.™ Nitinol Stent System implantation in approximately 250 patients with obstructive superficial femoral artery disease.

Official Title
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S.M.A.R.T.® Nitinol Self-Expandable Stent in the Treatment of Obstructive Superficial Femoral Artery Disease (STROLL)

Conditions
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Superficial Femoral Artery Disease

Intervention / Treatment
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* Device: S.M.A.R.T. ® Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 30 years For women of child bearing potential, a pregnancy test within 7 days prior to index procedure (the test results must be negative to be eligible). Symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4) with a resting or exercise ABI </= 0.8. A single superficial femoral artery lesion with > 50% stenosis or total occlusion. Stenotic lesion or occluded length within the same vessel (one long or multiple serial lesions) >/= 4.0 cm to </= 15.0 cm, by visual estimate. The stenosis must be treatable with no more than two stents, minimizing the stent overlap whose combined length </= 170 mm. Reference vessel diameter (RVD) >/= 4.0 mm and </= 6.0 mm by visual assessment. All lesions are to be located at least three centimeters proximal to the superior edge of the patella. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (< 50% stenosis) to the ankle or foot. The guidewire is across the target lesion(s) and located intraluminally within the distal vessel. Poor aortoiliac or common femoral inflow (i.e. angiographically defined > 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion. This can be done just prior to treatment of the target lesion. Successful treatment is defined as <30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, if the peak to peak pressure gradient across the inflow lesion is </= 20mmHg and the peak to peak pressure gradient across the SFA target lesion is >/= 20mmHg, then the patient will be included in the study. A patient with bilateral obstructive SFA disease is eligible for enrollment into the study. Eligibility for standard surgical repair, if necessary. A patient who requires a coronary intervention, should have it performed at least 7 days prior to the treatment of the target lesion. Patient or authorized representative must provide written informed consent and written HIPAA authorization prior to initiation of study procedures. Patient must be willing to comply with the specified follow-up evaluation schedule. Exclusion Criteria: Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days. Receiving dialysis or immunosuppressant therapy. Thrombolysis of the target vessel within 72 hours prior to the index procedure where complete resolution of the thrombus was not achieved. Recent stroke within past 90 days. Femoral, iliac or aortic aneurysm or aneurysm in the SFA or popliteal artery within past 5 years. Required stent placement via a popliteal approach. Required stent placement across or within 0.5 cm of the SFA / PFA bifurcation. 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. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device. Previously deployed stent within the SFA of the target limb. Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix®) or ticlopidine (Ticlid®), heparin, Nitinol (nickel titanium), contrast agent, that cannot be medically managed. Presence of thrombus prior to crossing the lesion Tissue loss due to ischemic disease (Rutherford/Becker category 5 or 6) Serum creatinine level >/= 2.5 mg/dl at time of screening visit Known or suspected active infection at the time of the procedure Bleeding diathesis Presence of an aortic, iliac or femoral artificial graft Life expectancy less than one year, or any other factors preventing clinical followup. Use of cryoplasty, laser, or atherectomy devices on the target vessel at the time of index procedure In-stent restenotic lesions at time of procedures. Restenotic lesion that had previously been treated by atherectomy, laser, or cryoplasty within 90 days of the index procedure. Patient is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol. Patient is known to be pregnant, incarcerated, mentally incompetent, and/or alcohol or drug abuser. Patient is currently participating in any other investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or future participation in such studies prior to the completion of this study. Patient has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study. Interventional procedures performed to the ipsilateral iliac artery to provide access will be allowed.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>S.M.A.R.T.® Nitinol Self-Expandable Stent System | Device: S.M.A.R.T. ® Stent<br>* The Cordis S.M.A.R.T.® Nitinol Stent System 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month Primary Patency Rate | Primary patency is defined as no significant reduction of flow detectable by Duplex ultrasound through the index lesion and no further clinically driven target vessel revascularization performed in the interim. Significant reduction of flow is binary restenosis defined as the diameter stenosis >50% with a peak systolic velocity ratio >2.0 as measured by Duplex ultrasound. | 12 months | 
| Primary Safety Endpoint | Primary safety endpoint is defined as the rate of freedom from all causes of death, index limb amputation, and clinically driven target lesion revascularization (TLR) through 30 days. A clinically driven TLR is any intervention in the stented target lesion following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise ABI ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target lesion with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death Rate at 30-day Post Procedure |  | 30 days | 
| Death at 12-month Post Procedure |  | 12 months | 
| Index Limb Amputation at 30-day Follow up | Index Limb Amputation is defined as surgical removal of all or part of the lower extremity from the toe up. | 30 day | 
| Clinically Driven Target Vessel Revascularization (TVR) at 30-day Post Procedure | A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven. | 30 days | 
| Clinically Driven Target Vessel Revascularization (TVR) at 12-month Post Procedure | A clinically driven TVR is any intervention of the target vessel following documented recurrent symptomatic leg ischemia by Rutherford/Becker Classification (category 2, 3 or 4), with a resting or exercise Ankle-Brachial Index (ABI) ≤ 0.8 and >50% diameter in-lesion stenosis by angiography. Revascularization of a target vessel with an in-lesion diameter stenosis of >70% by angiography, in the absence of the previously mentioned ischemic signs or symptoms, will also be considered clinically driven. | 12 months | 
| Stent Fracture at 12-month Follow Up | Stent fracture was assessed by x-ray evaluation. | 12 months | 
| Index Limb Ischemia at 6-month Follow up | Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6. | 6 months | 
| Index Limb Ischemia at 12-month Follow up | Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6. | 12 months | 
| Rutherford/Becker Classification at 30-day Follow Up | The Rutherford/Becker Classification is a commonly used clinical staging system which allows clinicians to describe and discuss patients with peripheral artery disease. The classification has seven stages as follows: Stage 0 - Asymptomatic, no hemodynamically significant occlusive disease Stage 1 - Mild claudication Stage 2 - Moderate claudication Stage 3 - Severe claudication Stage 4 - Ischemic rest pain Stage 5 - Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal ischemia Stage 6 - Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable | 30 days | 
| Rutherford / Becker Classification Category at 12-month Follow Up |  | 12 months | 
| Major Adverse Events at 12-month Post Procedure | Major adverse events included death, index limb ischemia, index limb amputation, clinically driven TLR, and significant embolic events, which were defined as causing end-organ damage. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Superficial Femoral Artery, Nitinol Self-Expandable Stent System