A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery

Study Overview
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Brief Summary
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OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a superficial femoral artery (SFA) stent procedure using the Misago™ Peripheral Self Expanding stent once all of the inclusion and none of the exclusion criteria are met. The stent efficacy and safety will be evaluated immediately post procedure, and at 30 days, 6, 12, 24, and 36 months post procedure. A subject is considered enrolled into the OSPREY study after he/she signs the informed consent and meets all inclusion/exclusion criteria. The study objectives are to demonstrate that efficacy and safety of this novel stent design are not inferior to historical Percutaneous Transluminal Angioplasty (PTA) and stent outcomes and meet the performance goals as published in the objective performance goals by Rocha-Singh, et al. This is a multi-center, single arm, non-randomized, prospective clinical trial of the Misago™ Self-Expanding Stent System for the treatment of atherosclerotic stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated at 12 months.

Official Title
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A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery

Conditions
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Peripheral Vascular Disease

Intervention / Treatment
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* Device: Misago™ Self-Expanding Stent System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-procedure: Female or male age greater than or equal to 18 years and of legal consent. Subjects must be willing to comply with the specified follow-up evaluation schedule. Informed consent (signed and dated) prior to any study-related evaluation or procedures. Symptomatic leg ischemia without tissue loss by Rutherford classification (category 2, 3 or 4). Resting ABI of <0.9, or abnormal exercise ABI. De novo lesion(s) (one or multiple lesions) with >50% stenosis, or occlusion which require treatment, and a total lesion length of >40 mm and <150 mm of the above-the-knee SFA in one limb. The target lesion should be treatable with no more than two overlapping stents, minimizing the stent overlap up to 10 mm (by visual estimate). All lesions are at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and at least 2 cm distal to the origin of the profunda artery. Reference vessel diameter of >4.0 mm and <7.0 mm. Target lesion length of > 40 mm and <150 mm. Patent popliteal artery (no stenosis > 50%) and at least one patent tibioperoneal run-off vessel with < 50% stenosis confirmed by angiography within 30 days of enrollment. Exclusion Criteria: Pre-existing autoimmune disease. Pre-existing terminal illness with life expectancy of less than three (3) years. Participation in another investigational device or therapeutic intervention trial within the past three (3) months. Previous enrollment in this study. Previous bypass surgery or stenting in the SFA or distally. Scheduled for a staged procedure to treat lesions within the aorta or run-off after enrollment. Co-existing aneurysmal disease of the aorta, iliac artery, SFA, or popliteal arteries requiring treatment. Any inflow disease of the ipsilateral pelvic arteries (more than 50 percent stenosis or occlusion) that has not been treated prior to enrollment (Treatment of iliac arteries before SFA intervention is permitted, except for common femoral stenosis). A recent (< 6 week) history of clinically significant gastrointestinal bleeding, major surgery, myocardial infarction or untreated coagulopathy. Known sensitivity or allergy to aspirin, radiographic contrast agents (that cannot be pre-treated adequately), nitinol, gold, or both heparin and bivalirudin. Angiographic evidence of acute thrombus. Sudden worsening of symptoms in the last 30 days. Subjects with acute/chronic renal dysfunction or estimated glomerular filtration rate (eGFR) <30 ml/min. Chronic hemodialysis subjects are not eligible for this protocol. Severe calcification or excessive tortuosity at target lesion. Subjects unable to tolerate anticoagulant therapy or antiplatelet therapy. Women who are currently pregnant. (A negative pregnancy test for female subjects of child bearing potential is required). The target lesion(s) cannot be successfully crossed with a guide wire.* Lower extremity deep venous thrombosis in the study limb within the prior 30 days. Chronic venous disease with active or recent (< 30 day) skin ulceration. Known or suspected active systemic infection. Two (2) months previous history of non-hemorrhagic stroke and or history of hemorrhagic stroke. Treatment that requires access via upper extremity, popliteal artery, or pedal artery. Evidence of severe or uncontrolled systemic disease of any condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol. Use of re-entry, ablative, or atherectomy devices to cross the lesion.*

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misago™ Self-Expanding Stent System<br> | Device: Misago™ Self-Expanding Stent System<br>* Transcatheter placement of an intravascular stent(s)<br>* Other names: OSPREY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | The primary effectiveness endpoint was defined as stent patency at 12 months as evidenced by absence of TLR and a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window. | 12 Months post-procedure | 
| Primary Safety Endpoint | The primary safety endpoint for this study was freedom from major adverse events (MAE) at 30 days post-procedure. MAE was defined as TLR, amputation of the treated limb, or death. | 30 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort | Primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from DUS obtained within the 12 months visit window. Because patency beyond the 12 months visit window may be considered as patency at 12 months, the out-of-window patency is imputed as treatment success. The modified intention to treat (mITT) cohort had 226 subjects (excluded subjects with unknown primary effectiveness endpoint). | 12 Months post-procedure | 
| Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort | The primary effectiveness endpoint was defined as absence of TLR and stent patency at 12 months as evidenced by a peak systolic velocity ratio < 2.0 from duplex ultrasound. Additional considerations were made using a more contemporary approach to evaluate stent patency using a peak systolic velocity ratio (PSVR) ≤ 2.4 (i.e., modified VIVA criteria). This outcome evaluated the modified intent-to-treat (mITT) cohort comprised of 226 subjects (excluded subjects with unknown primary effectiveness endpoint) | 12 Months post-procedure | 
| Occurrence of Target Lesion Revascularization | The occurrence of clinically driven Target Lesion Revascularization (TLR) was measured at 12 months post-procedure. Clinically driven defined as: More than 50 percent stenosis with worsening symptoms, OR More than 70 percent stenosis without symptoms | 12 Months post-procedure | 
| Device Related Peri-Procedural Complications | Peri-procedural (prior to discharge) measure of success (i.e., patency and none of the following: death, stroke, MI, embolization, thrombosis, and occlusion) | Prior to Hosptial Discharge | 
| Technical Success | Technical Success defined by the following conditions: Successful delivery of the stent at the lesion site Stent(s) successfully deployed in lesion with adequate lesion coverage | Intra-procedure | 
| Procedural Success | Procedural success defined as: attainment of < 30% residual stenosis of the target lesion and no peri-procedural complications defined as: death, stroke, myocardial infarction, emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel | Intra-procedure | 
| Clinical Success | Clinical success defined as: relief or improvement from baseline symptoms as measured by the Rutherford score for chronic limb ischemia at 30 days as compared to baseline | 30 days post-procedure | 
| Major Adverse Events (MAEs) Through 12 Months Post-procedure | The incidence of MAEs occurring within 12 months of the procedure. MAE is defined as target lesion revascularization (TLR), amputation of the treated limb, or death. | 12 Months post-procedure | 
| Stent Fracture at 12 Months | Occurrence of stent fracture as determined by core laboratory analysis | 12 Months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SFA, atherosclerotic stenosis, occlusions, Superficial Femoral Artery