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

OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a 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 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 MisagoTM self expanding stent for the treatment of atherosclerotic stenosis and occlusions of the SFA. The primary endpoint of stent patency will be evaluated at 12 months.

• Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9.
• Schulte KL, Kralj I, Gissler HM, Bagnaschino LA, Buschmann I, Pernès JM, Haage P, Goverde P, Beregi JP, Válka M, Boudny J, Geibel T, Velkoborsky M, Zähringer M, Paetzel C, Fanelli F, Müller-Hülsbeck S, Zeller T, Langhoff R. MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients. J Endovasc Ther. 2012 Dec;19(6):774-84. doi: 10.1583/JEVT-12-3861MR.1.

Inclusion Criteria:

Pre-procedure:

1. Female or male age greater than or equal to 18 years and of legal consent.
2. Subjects must be willing to comply with the specified follow-up evaluation schedule.
3. Informed consent (signed and dated) prior to any study-related evaluation or procedures.
4. Symptomatic leg ischemia without tissue loss by Rutherford classification (category 2, 3 or 4).
5. Resting ABI of <0.9, or abnormal exercise ABI.
6. 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).
7. 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.
8. Reference vessel diameter of >4.0 mm and <7.0 mm.
9. Target lesion length of > 40 mm and <150 mm.
10. 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:

1. Pre-existing autoimmune disease.
2. Pre-existing terminal illness with life expectancy of less than three (3) years.
3. Participation in another investigational device or therapeutic intervention trial within the past three (3) months.
4. Previous enrollment in this study.
5. Previous bypass surgery or stenting in the SFA or distally.
6. Scheduled for a staged procedure to treat lesions within the aorta or run-off after enrollment.
7. Co-existing aneurysmal disease of the aorta, iliac artery, SFA, or popliteal arteries requiring treatment.
8. 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).
9. A recent (< 6 week) history of clinically significant gastrointestinal bleeding, major surgery, myocardial infarction or untreated coagulopathy.
10. Known sensitivity or allergy to aspirin, radiographic contrast agents (that cannot be pre-treated adequately), nitinol, gold, or both heparin and bivalirudin.
11. Angiographic evidence of acute thrombus.
12. Sudden worsening of symptoms in the last 30 days.
13. Subjects with acute/chronic renal dysfunction or estimated glomerular filtration rate (eGFR) <30 ml/min. Chronic hemodialysis subjects are not eligible for this protocol.
14. Severe calcification or excessive tortuosity at target lesion.
15. Subjects unable to tolerate anticoagulant therapy or antiplatelet therapy.
16. Women who are currently pregnant. (A negative pregnancy test for female subjects of child bearing potential is required).
17. The target lesion(s) cannot be successfully crossed with a guide wire.*
18. Lower extremity deep venous thrombosis in the study limb within the prior 30 days.
19. Chronic venous disease with active or recent (< 30 day) skin ulceration.
20. Known or suspected active systemic infection.
21. Two (2) months previous history of non-hemorrhagic stroke and or history of hemorrhagic stroke.
22. Treatment that requires access via upper extremity, popliteal artery, or pedal artery.
23. 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.
24. Use of re-entry, ablative, or atherectomy devices to cross the lesion.*

• ClinLogix. LLC
• Massachusetts General Hospital
• Beth Israel Deaconess Medical Center