SuperNOVA Clinical Stenting Trial



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2011
End Date:July 2016

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Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System

The primary objective of this clinical study is to determine whether the Innova Stent System
shows acceptable performance in long-term (12-month) safety rates and vessel patency when
treating femoropopliteal lesions.

Atherosclerosis is a systemic disease that has become increasingly recognized in the
expanding elderly population as a significant cause of morbidity and mortality.
Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms
ranging from intermittent claudication to ischemic rest pain and critical ischemia with
major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully
treat with endovascular therapy because the disease is often diffuse and located in an area
of the body subject to significant mobility stresses such as extension, contraction,
compression, elongation, flexion and torsion.

The SuperNOVA clinical study is a prospective, single arm, controlled, multicenter, global
study. Approximately 50 centers located in the United States, Europe, Canada and/or
Australia are expected to participate in recruiting patients needing treatment of lesions in
their femoropopliteal arteries. A maximum of 300 subjects will be enrolled to ensure that a
minimum of 296 stented segments are treated with the Innova Stent System.

Inclusion Criteria:

1. Subjects age 18 and older

2. Chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4

3. Stenotic, restenotic (from angioplasty only) or occlusive lesion(s) located in the
native superficial femoral artery or proximal popliteal artery:

1. Degree of stenosis >/=70% by visual angiographic assessment

2. Vessel diameter >/= 4 and
3. Total lesion length (or series of lesions) >/=30mm and lesions may be treated, provided that the tandem lesion segment can be covered
with only one stent)

4. If lesion is restenotic, PTA treatment must be >3 months prior to stent
placement

5. Target lesion located at least three centimeters above the inferior edge of the
femur

4. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with
at least one of three vessels patent (<50% stenosis) to the ankle or foot

5. Subject (or Legal Guardian) is willing and able to provide consent before any
study-specific tests or procedures are performed and agrees to attend all required
follow-up visits

Exclusion Criteria:

1. Previous stent placement in the target vessel

2. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat
atherosclerotic disease

3. Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the
target SFA/PPA in the past 3 months

4. Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the
index procedure

5. History of major amputation in the same limb as the target lesion

6. Life expectancy less than 12 months due to other medical co-morbid condition(s) that
could limit the subject's ability to participate in the clinical study, limit the
subject's compliance with the follow-up requirements, or impact the scientific
integrity of the clinical study

7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of
the investigator, cannot be adequately pre-medicated.

8. Intolerance to antiplatelet, anticoagulant, or thrombolytic medications

9. Platelet count <150,000 mm3 or >600,000 mm3

10. Concomitant renal failure with a serum creatinine >2.0 mg/dL

11. Receiving dialysis or immunosuppressant therapy

12. Pregnancy

13. Current participation in another investigational drug or device clinical study

14. Known allergy to Nitinol

15. Septicemia at the time of the index procedure

16. Presence of other hemodynamically significant outflow lesions requiring intervention
within 30 days of the index procedure

17. Target lesion is within or near an aneurysm

18. Acute ischemia and/or acute thrombosis of the SFA/PPA

19. Persistent, intraluminal thrombus of the proposed target lesion post- thrombolytic
therapy

20. Perforated vessel as evidenced by extravasation of contrast media

21. Heavily calcified lesions
We found this trial at
29
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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Galveston, TX
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Atlanta, Georgia 30342
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Baltimore, Maryland 21287
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Birminham, Alabama 25235
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Bossier City, Louisiana 71111
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111 Colchester Ave
Burlington, Vermont 05401
(802) 847-0000
Fletcher Allen Health Care As Vermont’s University Medical Center, we at Fletcher Allen are committed...
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Burlington, VT
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Charlotte, North Carolina 28204
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Charlotte, NC
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111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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Dallas, Texas 75216
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Fort Worth, Texas 76104
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Fort Worth, TX
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Ft. Wayne, Indiana 46845
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Liverpool, New York 13203
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Memphis, Tennessee 35128
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800 E 28th St
Minneapolis, Minnesota 55407
(612) 863-4000
Abbott Northwestern Hospital Our hospital has a long and proud history as a health care...
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Nashville, Tennessee 37205
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New Orleans, Louisiana 70121
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4440 West 95th Street
Oak Lawn, Illinois 60453
708.684.8000
Advocate Christ Medical Center Advocate Health Care, named among the nation
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Peoria, Illinois 61614
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Petoskey, Michigan 49770
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Pittsburgh, Pennsylvania 15213
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Raliegh, North Carolina 27607
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Raliegh, NC
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Vienne,
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Wilmington, North Carolina 28401
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York, Pennsylvania 17315
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York, PA
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