Clinical trial NCT01292928: SuperNOVA Clinical Stenting Trial
Official title: Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis of Native Arteries of the Extremities, Unspecified
Keywords: Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, Stenting
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 \</= 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
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

Primary outcomes:
measure: Primary Safety Endpoint and Components
timeFrame: 1 month for death, 12 months for target limb major amputation , and target lesion revascularization
measure: Co-Primary Efficacy Endpoints
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Safety Endpoint and Components
timeFrame: 1 month
Other outcomes:
measure: Technical and Procedural Success
timeFrame: Up to 24 hours after the procedure
measure: Primary Patency
timeFrame: 12 months
measure: Assisted Primary Patency
timeFrame: 12 months
measure: Stent Fracture Rate
timeFrame: 12 months
measure: Rutherford Classification
timeFrame: 12 months
measure: Rate of Hemodynamic Improvement
timeFrame: 12 months
measure: Walking Improvement Assessed by the Walking Impairment Questionnaire
timeFrame: 12 months
measure: Walking Improvement (Time) Assessed by 6 Minute Hall Walk
timeFrame: 12 months
measure: Walking Improvement (Distance) Assessed by 6 Minute Hall Walk
timeFrame: 12 months
measure: Quality of Life
timeFrame: 12 months
Locations:
city: Birminham
country: United States
facility: Medical Center East
state: Alabama
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Atlanta
country: United States
facility: St. Joseph's Hospital of Atlanta
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Peoria
country: United States
facility: St. Francis Medical Center
state: Illinois
city: Ft. Wayne
country: United States
facility: Parkview Hospital
state: Indiana
city: Bossier City
country: United States
facility: Willis Knighton Bossier Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Frederick Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Liverpool
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Charlotte
country: United States
facility: Mid-Carolina Cardiology Presbyterian Hospital
state: North Carolina
city: Raliegh
country: United States
facility: Rex Hospital
state: North Carolina
city: Wilmington
country: United States
facility: Coastal Surgery Specialists
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC - Passavant
state: Pennsylvania
city: York
country: United States
facility: York Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Methodist North Hospital
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Research Institute, LLC
state: Tennessee
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
city: Fort Worth
country: United States
facility: Heart Center of Northe Texas
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care
state: Vermont
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Vienne
country: Austria
facility: Allgemeines Krankenhaus AKH
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius, Campus Dendermonde
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart Tienen
city: Sherbrook
country: Canada
facility: Fleurimont Hospital
state: Quebec
city: Guelph
country: Canada
facility: Guelph General Hospital
city: Montreal
country: Canada
facility: Hospital Maisonneuve-Rosemont
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Centre
city: Berlin
country: Germany
facility: Center or Diagnostic Radiology and Minimally Invasive Therapy / Gefäßzentrum am JuedischenKrankenhaus
city: Flensburg
country: Germany
facility: Ev. Luth. Diakonissenanstalt Flensburg
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH/Park Krankenhaus
city: Neumuenster
country: Germany
facility: Friedrich-Ebert-Krankenhaus Neumuenster GmbH
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Tokeidai Memorial Hospital
state: Hokkaido
city: Amagasaki-shi
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Kishiwada-shi
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka-fu
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Osaka
country: Japan
facility: Morinomiya Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Richard J Powell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rocha-Singh KJ, Jaff MR, Crabtree TR, Bloch DA, Ansel G; VIVA Physicians, Inc. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007 May 1;69(6):910-9. doi: 10.1002/ccd.21104.