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

This study is ongoing, but not recruiting participants.
ClinLogix. LLC
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Terumo Medical Corporation
ClinicalTrials.gov Identifier:
First received: May 4, 2010
Last updated: July 7, 2014
Last verified: July 2014

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.

Condition Intervention Phase
Peripheral Vascular Disease
Device: Misago™ Self-Expanding Stent System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery

Further study details as provided by Terumo Medical Corporation:

Primary Outcome Measures:
  • Efficacy and Safety [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    The primary efficacy endpoint will be primary stent patency rate at 12 months as confirmed by duplex ultrasound (DUS). The primary safety endpoint will be freedom from major adverse events (MAEs) within 30 days of the procedure that include target lesion revascularization,amputation of the treated limb, or subject death.

Secondary Outcome Measures:
  • Efficacy, Safety and Quality of Life [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]

Enrollment: 276
Study Start Date: July 2010
Estimated Study Completion Date: May 2016
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Non-Randomized Device: Misago™ Self-Expanding Stent System
Transcatheter placement of an intravascular stent(s)
Other Names:
  • Misago


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:


  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.*
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01118117

  Show 31 Study Locations
Sponsors and Collaborators
Terumo Medical Corporation
ClinLogix. LLC
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Principal Investigator: John F Angle, MD University of Virginia
  More Information

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Terumo Medical Corporation
ClinicalTrials.gov Identifier: NCT01118117     History of Changes
Other Study ID Numbers: TIS2009-02
Study First Received: May 4, 2010
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Terumo Medical Corporation:
atherosclerotic stenosis
Superficial Femoral Artery

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 29, 2015