Clinical trial NCT01118117: A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
Official title: A Multi-center Clinical Trial of the Misago™ Self-Expanding Stent System for Superficial Femoral Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Disease
Keywords: atherosclerotic stenosis
occlusions
Superficial Femoral Artery
SFA
Lead sponsor: Terumo Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: ClinLogix. LLC
name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2010-05-06
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.\*

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 12 Months post-procedure
measure: Primary Safety Endpoint
timeFrame: 30 days post-procedure
Secondary outcomes:
measure: Primary Effectiveness Endpoint in Modified Intent-to-Treat (mITT) Cohort
timeFrame: 12 Months post-procedure
measure: Primary Effectiveness Endpoint Using a Peak Systolic Velocity Ratio of ≤ 2.4 (i.e., Modified VIVA Criteria) in the mITT Cohort
timeFrame: 12 Months post-procedure
measure: Occurrence of Target Lesion Revascularization
timeFrame: 12 Months post-procedure
measure: Device Related Peri-Procedural Complications
timeFrame: Prior to Hosptial Discharge
measure: Technical Success
timeFrame: Intra-procedure
measure: Procedural Success
timeFrame: Intra-procedure
measure: Clinical Success
timeFrame: 30 days post-procedure
measure: Major Adverse Events (MAEs) Through 12 Months Post-procedure
timeFrame: 12 Months post-procedure
measure: Stent Fracture at 12 Months
timeFrame: 12 Months post-procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama
state: Alabama
city: Fairhope
country: United States
facility: Cardiology Associates of Mobile
state: Alabama
city: Little Rock
country: United States
facility: Central Arkansas Veteran's Healthcare System
state: Arkansas
city: Long Beach
country: United States
facility: Long Beach VA Healthcare Center
state: California
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Bradenton
country: United States
facility: Bradenton Cardiology Center
state: Florida
city: Gainesville
country: United States
facility: Florida Research Network
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Pensacola
country: United States
facility: Coastal Vascular and Interventional, PLLC
state: Florida
city: Elk Grove Village
country: United States
facility: Cardiovascular Associates
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Iowa City
country: United States
facility: University of Iowa Healthcare
state: Iowa
city: Ashland
country: United States
facility: Kings Daughters Medical Center
state: Kentucky
city: Ypsilanti
country: United States
facility: Michigan Heart
state: Michigan
city: Flemington
country: United States
facility: Hunterdon Cardiovascular Associates
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Hillsboro
country: United States
facility: Hillsboro Cardiology
state: Oregon
city: Doylestown
country: United States
facility: Central Bucks Specialists
state: Pennsylvania
city: Langhorne
country: United States
facility: St. Mary Medical Centere Research Institute
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Wyomissing
country: United States
facility: Berks Cardiologists, Ltd
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Heart Center
state: South Carolina
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Knoxville
country: United States
facility: Premier Clinical Reesearch
state: Tennessee
city: Knoxville
country: United States
facility: East Tennessee Cardiovascular Research-Turkey Creek Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Heart Clinical Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Lynchburg
country: United States
facility: Centra Cardiovascular Group
state: Virginia
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Milwaukee
country: United States
facility: Columbia- St. Mary's
state: Wisconsin
Study officials:
affiliation: University of Virginia
name: John F Angle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.