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

NCT01118117 | Completed Results DMC

• 1 other identifier: TIS2009-02
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 31

Brief Summary

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.

Conditions

Peripheral Vascular Disease

Keywords

atherosclerotic stenosis; occlusions; Superficial Femoral Artery; SFA

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort

  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

  12 Months post-procedure

• Occurrence of Target Lesion Revascularization

  12 Months post-procedure

• Device Related Peri-Procedural Complications

  Prior to Hosptial Discharge

• Technical Success

  Intra-procedure

Study Arms (1)

Misago™ Self-Expanding Stent System

EXPERIMENTAL

Device: Misago™ Self-Expanding Stent System

Interventions

Misago™ Self-Expanding Stent System DEVICE

Transcatheter placement of an intravascular stent(s)

Also known as: Misago, OSPREY

Misago™ Self-Expanding Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Terumo Medical Corporation: lead
• ClinLogix. LLC: collaborator
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (31)

University Of Alabama

Birmingham, Alabama, 35294, United States

Location

Cardiology Associates of Mobile

Fairhope, Alabama, 36532, United States

Location

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Long Beach VA Healthcare Center

Long Beach, California, 90822, United States

Location

Christiana Care

Newark, Delaware, 19718, United States

Location

Bradenton Cardiology Center

Bradenton, Florida, 34205, United States

Location

Florida Research Network

Gainesville, Florida, 32605, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Coastal Vascular and Interventional, PLLC

Pensacola, Florida, 32504, United States

Location

Cardiovascular Associates

Elk Grove Village, Illinois, 60007, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

University of Iowa Healthcare

Iowa City, Iowa, 52242, United States

Location

Kings Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

Michigan Heart

Ypsilanti, Michigan, 48197, United States

Location

Hunterdon Cardiovascular Associates

Flemington, New Jersey, 08822, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Hillsboro Cardiology

Hillsboro, Oregon, 97123, United States

Location

Central Bucks Specialists

Doylestown, Pennsylvania, 18901, United States

Location

St. Mary Medical Centere Research Institute

Langhorne, Pennsylvania, 19047, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

Berks Cardiologists, Ltd

Wyomissing, Pennsylvania, 19610, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

South Carolina Heart Center

Columbia, South Carolina, 29204, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Premier Clinical Reesearch

Knoxville, Tennessee, 37909, United States

Location

East Tennessee Cardiovascular Research-Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Amarillo Heart Clinical Research Institute

Amarillo, Texas, 79106, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Centra Cardiovascular Group

Lynchburg, Virginia, 24501, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

Columbia- St. Mary's

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (3)

• 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.

  PMID: 17377972 BACKGROUND

• 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.

  PMID: 26483003 DERIVED

• 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.

  PMID: 23210876 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Bites and Stings

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Results Point of Contact

• Title: Adam Thompson, Clinical Program Manager
• Organization: Terumo Medical Corporation

adam.thompson@terumomedical.com

201-398-3283

Study Officials

• John F Angle, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 6, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: April 1, 2016
• Last Updated: November 20, 2017
• Results First Posted: July 14, 2015

Record last verified: 2017-10

Locations

US (31)