SuperNOVA Clinical Stenting Trial

Completed · Not applicable

Conditions studied: Atherosclerosis of Native Arteries of the Extremities, Unspecified

In brief

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.

Key facts

Study ID

NCT01292928

Run by

Boston Scientific Corporation

People needed

299

Starts

2011-04-01

Expected to finish

2016-09-01

Last updated by the study team

2017-03-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects age 18 and older
• Chronic symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
• Stenotic, restenotic (from angioplasty only) or occlusive lesion(s) located in the native superficial femoral artery or proximal popliteal artery:
• Degree of stenosis >/=70% by visual angiographic assessment
• Vessel diameter >/= 4 and </= 7mm
• Total lesion length (or series of lesions) >/=30mm and </= 190 mm (note: tandem lesions may be treated, provided that the tandem lesion segment can be covered with only one stent)
• If lesion is restenotic, PTA treatment must be >3 months prior to stent placement
• Target lesion located at least three centimeters above the inferior edge of the femur
• 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
• 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

You may not qualify if…

• Previous stent placement in the target vessel
• Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease
• Subjects who have undergone prior percutaneous transluminal angioplasty (PTA) in the target SFA/PPA in the past 3 months
• Use of atherectomy devices or other adjunctive treatment in the SFA/PPA during the index procedure
• History of major amputation in the same limb as the target lesion
• 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
• Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
• Intolerance to antiplatelet, anticoagulant, or thrombolytic medications
• Platelet count <150,000 mm3 or >600,000 mm3
• Concomitant renal failure with a serum creatinine >2.0 mg/dL
• Receiving dialysis or immunosuppressant therapy
• Pregnancy
• Current participation in another investigational drug or device clinical study
• Known allergy to Nitinol
• Septicemia at the time of the index procedure
• Presence of other hemodynamically significant outflow lesions requiring intervention within 30 days of the index procedure
• Target lesion is within or near an aneurysm
• Acute ischemia and/or acute thrombosis of the SFA/PPA
• Persistent, intraluminal thrombus of the proposed target lesion post- thrombolytic therapy
• Perforated vessel as evidenced by extravasation of contrast media
• Heavily calcified lesions

Where it is running

• Medical Center East — Birminham, Alabama, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• St. Joseph's Hospital of Atlanta — Atlanta, Georgia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• St. Francis Medical Center — Peoria, Illinois, United States
• Parkview Hospital — Fort Wayne, Indiana, United States
• Willis Knighton Bossier Medical Center — Bossier City, Louisiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Frederick Memorial Hospital — Baltimore, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Northern Michigan Hospital — Petoskey, Michigan, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• St. Joseph's Hospital Health Center — Liverpool, New York, United States
• Mid-Carolina Cardiology Presbyterian Hospital — Charlotte, North Carolina, United States
• Rex Hospital — Raliegh, North Carolina, United States
• Coastal Surgery Specialists — Wilmington, North Carolina, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Grant Medical Center — Columbus, Ohio, United States
• UPMC - Passavant — Pittsburgh, Pennsylvania, United States
• York Hospital — York, Pennsylvania, United States
• Methodist North Hospital — Memphis, Tennessee, United States
• St. Thomas Research Institute, LLC — Nashville, Tennessee, United States
• VA North Texas Health Care System — Dallas, Texas, United States
• Heart Center of Northe Texas — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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