SuperNOVA Clinical Stenting Trial

NCT ID: NCT01292928

Last Updated: 2017-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2016-09-30

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.

Conditions

Atherosclerosis of Native Arteries of the Extremities, Unspecified

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stent

Stent implantation into SFA/PPA

Group Type: EXPERIMENTAL

Stent implantation

Intervention Type: DEVICE

Stent implantation during the index procedure.

Interventions

Stent implantation

Stent implantation during the index procedure.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard J Powell, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Mid-Carolina Cardiology Presbyterian Hospital

Charlotte, North Carolina, United States

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

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

University of Texas Medical Branch

Galveston, Texas, United States

Fletcher Allen Health Care

Burlington, Vermont, United States

Swedish Medical Center

Seattle, Washington, United States

Allgemeines Krankenhaus AKH

Vienna, , Austria

Imelda Ziekenhuis

Bonheiden, , Belgium

AZ Sint-Blasius, Campus Dendermonde

Dendermonde, , Belgium

Ziekenhuis Oost Limburg

Genk, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, , Belgium

Fleurimont Hospital

Sherbrook, Quebec, Canada

Guelph General Hospital

Guelph, , Canada

Hospital Maisonneuve-Rosemont

Montreal, , Canada

Winnipeg Health Sciences Centre

Winnipeg, , Canada

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

Berlin, , Germany

Ev. Luth. Diakonissenanstalt Flensburg

Flensburg, , Germany

Herzzentrum Leipzig GmbH/Park Krankenhaus

Leipzig, , Germany

Friedrich-Ebert-Krankenhaus Neumuenster GmbH

Neumünster, , Germany

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, Japan

Tokeidai Memorial Hospital

Sapporo, Hokkaido, Japan

Kansai Rosai Hospital

Amagasaki-shi, Hyōgo, Japan

Kishiwada Tokushukai Hospital

Kishiwada-shi, Osaka, Japan

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Morinomiya Hospital

Osaka, , Japan

Northern General Hospital

Sheffield, , United Kingdom

Countries

United States; Austria; Belgium; Canada; Germany; Japan; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 17377972 (View on PubMed)

Other Identifiers

G100291

Identifier Type: -

Identifier Source: org_study_id