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

Phase 2
18 Years
Open (Enrolling)
Peripheral Vascular Disease

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Trial Information

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

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

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

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

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

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

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

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.*

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy and Safety

Outcome Description:

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.

Outcome Time Frame:

12 Months

Safety Issue:


Principal Investigator

John F Angle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia


United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

June 2015

Related Keywords:

  • Peripheral Vascular Disease
  • atherosclerotic stenosis
  • occlusions
  • Superficial Femoral Artery
  • SFA
  • Vascular Diseases
  • Peripheral Vascular Diseases
  • Peripheral Arterial Disease



University of Alabama Birmingham, Alabama  
Medical University of South Carolina Charleston, South Carolina  29425-0721
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
University of Oklahoma Oklahoma City, Oklahoma  73190
University of Virginia Charlottesville, Virginia  22908
Columbia University Medical Center New York, New York  10032
Sentara Medical Group Norfolk, Virginia  23502
Christiana Care Newark, Delaware  19718
Franciscan Research Center Tacoma, Washington  98405
Bradenton Cardiology Center Bradenton, Florida  34205
First Coast Cardiovascular Institute Jacksonville, Florida  32216
Cardiovascular Associates Elk Grove Village, Illinois  60007
Methodist Cardiology Physicians Indianapolis, Indiana  46202
Midwest Cardiovascular Research Foundation Davenport, Iowa  52803
Kings Daughters Medical Center Ashland, Kentucky  41101
Hillsboro Cardiology Hillsboro, Oregon  97123
Central Bucks Specialists Doylestown, Pennsylvania  18901
South Carolina Heart Center Columbia, South Carolina  29204
Centra Cardiovascular Group Lynchburg, Virginia  24501
Columbia- St. Mary's Milwaukee, Wisconsin  53211