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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ClinLogix. LLC
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Terumo Medical Corporation
ClinicalTrials.gov Identifier:
NCT01118117
First received: May 4, 2010
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

OSPREY is a multi-center, single arm, non-randomized, prospective clinical trial. Subjects will undergo a 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 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 MisagoTM self expanding stent 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: Allocation: Non-Randomized
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(TM) Self Expanding Stent System for Superficial Femoral Artery

Resource links provided by NLM:


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)or angiography. 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 death.


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

Estimated Enrollment: 250
Study Start Date: July 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 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
  • OSPREY

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.*
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01118117

Locations
United States, Alabama
University Of Alabama
Birmingham, Alabama, United States, 35294
United States, Delaware
Christiana Care
Newark, Delaware, United States, 19718
United States, Florida
Bradenton Cardiology Center
Bradenton, Florida, United States, 34205
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32216
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Cardiovascular Associates
Elk Grove Village, Illinois, United States, 60007
United States, Indiana
Methodist Cardiology Physicians
Indianapolis, Indiana, United States, 46202
United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803
United States, Kentucky
Kings Daughters Medical Center
Ashland, Kentucky, United States, 41101
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Hillsboro Cardiology
Hillsboro, Oregon, United States, 97123
United States, Pennsylvania
Central Bucks Specialists
Doylestown, Pennsylvania, United States, 18901
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29401
South Carolina Heart Center
Columbia, South Carolina, United States, 29204
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Centra Cardiovascular Group
Lynchburg, Virginia, United States, 24501
Sentara Medical Group
Norfolk, Virginia, United States, 23507
United States, Washington
Franciscan Research Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Columbia- St. Mary's
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Terumo Medical Corporation
ClinLogix. LLC
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: John F Angle, MD University of Virginia
  More Information

Publications:
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: April 22, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 16, 2014