A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
NCT ID: NCT01118117
Last Updated: 2017-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
NA
276 participants
INTERVENTIONAL
2010-07-31
2016-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Misago™ Self-Expanding Stent System
Misago™ Self-Expanding Stent System
Transcatheter placement of an intravascular stent(s)
Interventions
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Misago™ Self-Expanding Stent System
Transcatheter placement of an intravascular stent(s)
Other Intervention Names
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Eligibility Criteria
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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
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.\*
18 Years
ALL
Yes
Sponsors
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ClinLogix. LLC
INDUSTRY
Massachusetts General Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Terumo Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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John F Angle, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University Of Alabama
Birmingham, Alabama, United States
Cardiology Associates of Mobile
Fairhope, Alabama, United States
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States
Long Beach VA Healthcare Center
Long Beach, California, United States
Christiana Care
Newark, Delaware, United States
Bradenton Cardiology Center
Bradenton, Florida, United States
Florida Research Network
Gainesville, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Coastal Vascular and Interventional, PLLC
Pensacola, Florida, United States
Cardiovascular Associates
Elk Grove Village, Illinois, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
University of Iowa Healthcare
Iowa City, Iowa, United States
Kings Daughters Medical Center
Ashland, Kentucky, United States
Michigan Heart
Ypsilanti, Michigan, United States
Hunterdon Cardiovascular Associates
Flemington, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Hillsboro Cardiology
Hillsboro, Oregon, United States
Central Bucks Specialists
Doylestown, Pennsylvania, United States
St. Mary Medical Centere Research Institute
Langhorne, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
Berks Cardiologists, Ltd
Wyomissing, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
South Carolina Heart Center
Columbia, South Carolina, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Premier Clinical Reesearch
Knoxville, Tennessee, United States
East Tennessee Cardiovascular Research-Turkey Creek Medical Center
Knoxville, Tennessee, United States
Amarillo Heart Clinical Research Institute
Amarillo, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Centra Cardiovascular Group
Lynchburg, Virginia, United States
Sentara Medical Group
Norfolk, Virginia, United States
Columbia- St. Mary's
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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TIS2009-02
Identifier Type: -
Identifier Source: org_study_id