A Multi-center Clinical Trial of the Misago™ 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 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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: Misago™ Self-Expanding Stent System

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama
    • Fairhope, Alabama, United States, 36532
      • Cardiology Associates of Mobile
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Central Arkansas Veteran's Healthcare System
  • California
    • Long Beach, California, United States, 90822
      • Long Beach VA Healthcare Center
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Care
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Cardiology Center
    • Gainesville, Florida, United States, 32605
      • Florida Research Network
    • Jacksonville, Florida, United States, 32216
      • First Coast Cardiovascular Institute
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular and Interventional, PLLC
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Cardiovascular Associates
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Midwest Cardiovascular Research Foundation
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Healthcare
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Kings Daughters Medical Center
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Michigan Heart
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Hunterdon Cardiovascular Associates
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Oregon
    • Hillsboro, Oregon, United States, 97123
      • Hillsboro Cardiology
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Central Bucks Specialists
    • Langhorne, Pennsylvania, United States, 19047
      • St. Mary Medical Centere Research Institute
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health Cardiovascular Institute
    • Wyomissing, Pennsylvania, United States, 19610
      • Berks Cardiologists, LTD
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Medical University of South Carolina
    • Columbia, South Carolina, United States, 29204
      • South Carolina Heart Center
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute
    • Knoxville, Tennessee, United States, 37909
      • Premier Clinical Reesearch
    • Knoxville, Tennessee, United States, 37934
      • East Tennessee Cardiovascular Research-Turkey Creek Medical Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Heart Clinical Research Institute
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Lynchburg, Virginia, United States, 24501
      • Centra Cardiovascular Group
    • Norfolk, Virginia, United States, 23507
      • Sentara Medical Group
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia- St. Mary's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.*

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Terumo Medical Corporation
• Collaborators: Massachusetts General Hospital; Beth Israel Deaconess Medical Center; ClinLogix. LLC
• Investigators: Principal Investigator: John F Angle, MD, University of Virginia

Publications and helpful links

General Publications

• 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. doi: 10.1002/ccd.21104.
• Ohki T, Angle JF, Yokoi H, Jaff MR, Popma J, Piegari G, Kanaoka Y; OSPREY investigators. One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study). J Vasc Surg. 2016 Feb;63(2):370-6.e1. doi: 10.1016/j.jvs.2015.08.093. Epub 2015 Oct 17.
• Schulte KL, Kralj I, Gissler HM, Bagnaschino LA, Buschmann I, Pernes JM, Haage P, Goverde P, Beregi JP, Valka M, Boudny J, Geibel T, Velkoborsky M, Zahringer M, Paetzel C, Fanelli F, Muller-Hulsbeck 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 4, 2010
• First Posted (Estimate): May 6, 2010

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: SFA; atherosclerotic stenosis; occlusions; Superficial Femoral Artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: TIS2009-02