SuperNOVA Clinical Stenting Trial

NCT01292928 | Completed Results

• 1 other identifier: G100291
• Study Type: interventional
• Target: 299
• Locations: 7 countries
• Sites: 49

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.

Conditions

Atherosclerosis of Native Arteries of the Extremities, Unspecified

Keywords

Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, Stenting

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint and Components

  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

  1 month for death, 12 months for target limb major amputation , and target lesion revascularization

• Co-Primary Efficacy Endpoints

  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).

  12 months

Secondary Outcomes (1)

• Secondary Safety Endpoint and Components

  1 month

Other Outcomes (10)

• Technical and Procedural Success

  Up to 24 hours after the procedure

• Primary Patency

  12 months

• Assisted Primary Patency

  12 months

Study Arms (1)

Stent

EXPERIMENTAL

Stent implantation into SFA/PPA

Device: Stent implantation

Interventions

Stent implantation DEVICE

Stent implantation during the index procedure.

Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (49)

Medical Center East

Birminham, Alabama, 25235, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

St. Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

St. Francis Medical Center

Peoria, Illinois, 61614, United States

Location

Parkview Hospital

Fort Wayne, Indiana, 46805, United States

Location

Willis Knighton Bossier Medical Center

Bossier City, Louisiana, 71111, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Frederick Memorial Hospital

Baltimore, Maryland, 21287, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 05115, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

St. Joseph's Hospital Health Center

Liverpool, New York, 13203, United States

Location

Mid-Carolina Cardiology Presbyterian Hospital

Charlotte, North Carolina, 28204, United States

Location

Rex Hospital

Raliegh, North Carolina, 27607, United States

Location

Coastal Surgery Specialists

Wilmington, North Carolina, 28401, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Grant Medical Center

Columbus, Ohio, 43215, United States

Location

UPMC - Passavant

Pittsburgh, Pennsylvania, 15213, United States

Location

York Hospital

York, Pennsylvania, 17405, United States

Location

Methodist North Hospital

Memphis, Tennessee, 35128, United States

Location

St. Thomas Research Institute, LLC

Nashville, Tennessee, 37205, United States

Location

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Heart Center of Northe Texas

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Allgemeines Krankenhaus AKH

Vienna, A- 1090, Austria

Location

Imelda Ziekenhuis

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius, Campus Dendermonde

Dendermonde, 9200, Belgium

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, 3300, Belgium

Location

Fleurimont Hospital

Sherbrook, Quebec, J1H 5N4, Canada

Location

Guelph General Hospital

Guelph, N1E 6L9, Canada

Location

Hospital Maisonneuve-Rosemont

Montreal, H1T 2M4, Canada

Location

Winnipeg Health Sciences Centre

Winnipeg, R3A 1R9, Canada

Location

Center or Diagnostic Radiology and Minimally Invasive Therapy / Gefäßzentrum am JuedischenKrankenhaus

Berlin, 13347, Germany

Location

Ev. Luth. Diakonissenanstalt Flensburg

Flensburg, 24939, Germany

Location

Herzzentrum Leipzig GmbH/Park Krankenhaus

Leipzig, 04289, Germany

Location

Friedrich-Ebert-Krankenhaus Neumuenster GmbH

Neumünster, 24534, Germany

Location

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, 802-8055, Japan

Location

Tokeidai Memorial Hospital

Sapporo, Hokkaido, 060-0031, Japan

Location

Kansai Rosai Hospital

Amagasaki-shi, Hyōgo, 660-8511, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada-shi, Osaka, 596-8522, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Morinomiya Hospital

Osaka, 536-0025, Japan

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 17377972 BACKGROUND

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Philip Ghizoni, Clinical Trial Manager
• Organization: Boston Scientific Corporation

Philip.Ghizoni@bsci.com

763-255-0036

Study Officials

• Richard J Powell, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2016
• Last Updated: March 8, 2017
• Results First Posted: January 20, 2016

Record last verified: 2017-01

Locations

DE (4); AU (1); JP (6); CA (4); GB (1); US (28); BE (5)