SuperNOVA Clinical Stenting Trial

Not Applicable

Completed

Conditions: Atherosclerosis of Native Arteries of the Extremities, Unspecified

Interventions: Device: Stent implantation

Registration Number: NCT01292928

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 299

Inclusion Criteria

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:
1. Degree of stenosis >/=70% by visual angiographic assessment
2. Vessel diameter >/= 4 and </= 7mm
3. 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)
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
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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stent	Stent implantation	Stent implantation into SFA/PPA

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint and Components	1 month for death, 12 months for target limb major amputation , and target lesion revascularization	The safety endpoint assesses the occurrence of Major Adverse Events (MAEs) defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization through 12 months
Co-Primary Efficacy Endpoints	12 months	The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure. * The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm). * The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm).

Secondary Outcome Measures

Name	Time	Method
Secondary Safety Endpoint and Components	1 month	The secondary safety endpoint assesses the occurrence of Major Adverse Events (MAEs) through 30 days. MAEs will include all causes of death, target limb major amputation and/or target lesion revascularization through 1 month

Trial Locations

Locations (49): Dartmouth Hitchcock Medical Center
🇺🇸
Lebanon, New Hampshire, United States
Universitair Ziekenhuis Gent
🇧🇪
Gent, Belgium
Kansai Rosai Hospital
🇯🇵
Amagasaki-shi, Hyogo, Japan
Imelda Ziekenhuis
🇧🇪
Bonheiden, Belgium
Guelph General Hospital
🇨🇦
Guelph, Canada
Medical Center East
🇺🇸
Birminham, Alabama, United States
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Kokura Memorial Hospital
🇯🇵
Kitakyushu-shi, Fukuoka, Japan
Fleurimont Hospital
🇨🇦
Sherbrook, Quebec, Canada
Allgemeines Krankenhaus AKH
🇦🇹
Vienne, Austria
Parkview Hospital
🇺🇸
Ft. Wayne, Indiana, United States
St. Thomas Research Institute, LLC
🇺🇸
Nashville, Tennessee, United States
Rex Hospital
🇺🇸
Raliegh, North Carolina, United States
Methodist North Hospital
🇺🇸
Memphis, Tennessee, United States
Ziekenhuis Oost Limburg
🇧🇪
Genk, Belgium
St. Joseph's Hospital of Atlanta
🇺🇸
Atlanta, Georgia, United States
Regionaal Ziekenhuis Heilig Hart Tienen
🇧🇪
Tienen, Belgium
St. Francis Medical Center
🇺🇸
Peoria, Illinois, United States
Hospital Maisonneuve-Rosemont
🇨🇦
Montreal, Canada
Winnipeg Health Sciences Centre
🇨🇦
Winnipeg, Canada
Ev. Luth. Diakonissenanstalt Flensburg
🇩🇪
Flensburg, Germany
Tokeidai Memorial Hospital
🇯🇵
Sapporo-shi, Hokkaido, Japan
Frederick Memorial Hospital
🇺🇸
Baltimore, Maryland, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Grant Medical Center
🇺🇸
Columbus, Ohio, United States
VA North Texas Health Care System
🇺🇸
Dallas, Texas, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
UPMC - Passavant
🇺🇸
Pittsburgh, Pennsylvania, United States
York Hospital
🇺🇸
York, Pennsylvania, United States
Northern Michigan Hospital
🇺🇸
Petoskey, Michigan, United States
Mid-Carolina Cardiology Presbyterian Hospital
🇺🇸
Charlotte, North Carolina, United States
Abbott Northwestern Hospital
🇺🇸
Minneapolis, Minnesota, United States
St. Joseph's Hospital Health Center
🇺🇸
Liverpool, New York, United States
Coastal Surgery Specialists
🇺🇸
Wilmington, North Carolina, United States
Fletcher Allen Health Care
🇺🇸
Burlington, Vermont, United States
AZ Sint-Blasius, Campus Dendermonde
🇧🇪
Dendermonde, Belgium
Center or Diagnostic Radiology and Minimally Invasive Therapy / Gefäßzentrum am JuedischenKrankenhaus
🇩🇪
Berlin, Germany
Herzzentrum Leipzig GmbH/Park Krankenhaus
🇩🇪
Leipzig, Germany
Friedrich-Ebert-Krankenhaus Neumuenster GmbH
🇩🇪
Neumuenster, Germany
Kishiwada Tokushukai Hospital
🇯🇵
Kishiwada-shi, Osaka-fu, Japan
Tokyo Women's Medical University Hospital
🇯🇵
Shinjuku-ku, Tokyo, Japan
Morinomiya Hospital
🇯🇵
Osaka, Japan
Northern General Hospital
🇬🇧
Sheffield, United Kingdom
University of Texas Medical Branch
🇺🇸
Galveston, Texas, United States
Heart Center of Northe Texas
🇺🇸
Fort Worth, Texas, United States
Willis Knighton Bossier Medical Center
🇺🇸
Bossier City, Louisiana, United States