SuperNOVA Clinical Stenting Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01292928
First received: February 9, 2011
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Atherosclerosis of Native Arteries of the Extremities, Unspecified
Device: Stent implantation
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stenting of the Superficial Femoral and Proximal Popliteal Arteries With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Safety Rate/Vessel patency [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Additional Data [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Secondary objectives of this clinical study are to provide additional data surrounding the use of the Innova Stent System in treating femoropopliteal lesions, inclusive of an assessment of any quality of life improvement noted by the subjects, clinical improvement documented by the Investigators, and an evaluation of stent fractures.


Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stent
Stent implantation into SFA/PPA
Device: Stent implantation
Stent implantation during the index procedure.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292928

  Hide Study Locations
Locations
United States, Alabama
Medical Center East
Birminham, Alabama, United States, 25235
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
United States, Illinois
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453
St. Francis Medical Center
Peoria, Illinois, United States, 61614
United States, Indiana
Parkview Hospital
Ft. Wayne, Indiana, United States, 46805
United States, Louisiana
Willis Knighton Bossier Medical Center
Bossier City, Louisiana, United States, 71111
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
Frederick Memorial Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 05115
United States, Michigan
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
St. Joseph's Hospital Health Center
Liverpool, New York, United States, 13203
United States, North Carolina
Mid-Carolina Cardiology Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Rex Hospital
Raliegh, North Carolina, United States, 27607
Coastal Surgery Specialists
Wilmington, North Carolina, United States, 28401
United States, Ohio
Grant Medical Center
Columbus, Ohio, United States, 43215
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
UPMC - Passavant
Pittsburgh, Pennsylvania, United States, 15213
York Hospital
York, Pennsylvania, United States, 17405
United States, Tennessee
Methodist North Hospital
Memphis, Tennessee, United States, 35128
St. Thomas Research Institute, LLC
Nashville, Tennessee, United States, 37205
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
Heart Center of Northe Texas
Fort Worth, Texas, United States, 76104
University of Texas Medical Branch
Galveston, Texas, United States, 77555
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Austria
Allgemeines Krankenhaus AKH
Vienne, Austria, A- 1090
Belgium
Imelda Ziekenhuis
Bonheiden, Belgium, 2820
AZ Sint-Blasius, Campus Dendermonde
Dendermonde, Belgium, 9200
Ziekenhuis Oost Limburg
Genk, Belgium, 3600
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Regionaal Ziekenhuis Heilig Hart Tienen
Tienen, Belgium, 3300
Canada, Quebec
Fleurimont Hospital
Sherbrook, Quebec, Canada, J1H 5N4
Canada
Guelph General Hospital
Guelph, Canada, N1E 6L9
Hospital Maisonneuve-Rosemont
Montreal, Canada, H1T 2M4
Winnipeg Health Sciences Centre
Winnipeg, Canada, R3A 1R9
Germany
Center or Diagnostic Radiology and Minimally Invasive Therapy / Gefäßzentrum am JuedischenKrankenhaus
Berlin, Germany, 13347
Ev. Luth. Diakonissenanstalt Flensburg
Flensburg, Germany, 24939
Herzzentrum Leipzig GmbH/Park Krankenhaus
Leipzig, Germany, 04289
Friedrich-Ebert-Krankenhaus Neumuenster GmbH
Neumuenster, Germany, 24534
Japan
Kokura Memorial Hospital
Kitakyushu-shi, Fukuoka, Japan, 802-8055
Tokeidai Memorial Hospital
Sapporo-shi, Hokkaido, Japan, 060-0031
Kansai Rosai Hospital
Amagasaki-shi, Hyogo, Japan, 660-8511
Kishiwada Tokushukai Hospital
Kishiwada-shi, Osaka-fu, Japan, 596-8522
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 162-8666
Morinomiya Hospital
Osaka, Japan, 536-0025
United Kingdom
Northern General Hospital
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Richard J Powell, MD Dartmouth-Hitchcock Medical Center
  More Information

Publications:
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01292928     History of Changes
Other Study ID Numbers: G100291
Study First Received: February 9, 2011
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Atherosclerosis, SFA, PPA, lower extremities, Stenting

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014