SuperNOVA Clinical Stenting Trial

Stenting of the Superficial Femoral (SFA) and Proximal Popliteal Arteries (PPA) With the Boston Scientific INNOVA Self-Expanding Bare Metal Stent System

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis of Native Arteries of the Extremities, Unspecified
• Intervention / Treatment: Device: Stent implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Stent; Stent implantation into SFA/PPA	Device: Stent implantation; Stent implantation during the index procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint and Components	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	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical and Procedural Success	Technical success: ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%; Procedural success: technical success with no MAEs within 24 hours of the procedure	Up to 24 hours after the procedure
Primary Patency	Primary patency is the percentage of lesions (target stented segments) that reach a time point without a hemodynamically significant stenosis assessed by Duplex Ultrasound (DUS) and without Target Lesion Revascularization (TLR) or bypass of the target lesion.	12 months
Assisted Primary Patency	Assisted primary patency is the percentage of lesions without TLR and those with TLR (not due to complete occlusion or bypass) that reach a time point without restenosis.	12 months
Stent Fracture Rate	Vascular InterVentional Advances (VIVA) definitions: Grade 0: No strut fractures Grade I: single strut fracture Grade II: multiple strut fractures Grade III: stent fracture(s) with preserved alignment of the components Grade IV: stent fracture(s) with mal-alignment of the components Grade V: stent fracture(s) in a trans-axial spiral configuration	12 months
Rutherford Classification	Class 0: Asymptomatic Class 1: Mild claudication Class 2: Moderate claudication Class 3: Severe claudication Class 4: Ischemic rest pain Class 5: Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal edema Class 6: Major tissue loss - extending above metatarsal (MT) level Rate of Primary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure without the need for repeat TLR. Rate of Secondary Sustained Clinical Improvement: an improvement in Rutherford classification of one or more categories as compared to pre-procedure including those subjects with repeat TLR. Rate of Clinical Deterioration: downgrade in Rutherford classification of one or more categories as compared to pre-procedure	12 months
Rate of Hemodynamic Improvement	The Ankle-Brachial Index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm. Hemodynamic Improvement: Increases in ABI of ≥ 0.10 or to an ABI ≥ 0.90 as compared to pre-procedure without the need for repeat TLR. Hemodynamic Improvement (Including TLR): Increases in ABI of ≥0.10 or to an ABI ≥0.90 as compared to pre-procedure including TLR.	12 months
Walking Improvement Assessed by the Walking Impairment Questionnaire	The Walking Impairment Questionnaire (WIQ) is a validated functional assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.	12 months
Walking Improvement (Time) Assessed by 6 Minute Hall Walk	Assessment of walking improvement (time) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.	12 months
Walking Improvement (Distance) Assessed by 6 Minute Hall Walk	Assessment of walking improvement (distance) by the administration of the 6 Minute Walk Test (6MWT). Participants were asked to walk for as long as they could; up to 6 minutes.	12 months
Quality of Life	Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health). The SF-36 is a multipurpose, proprietary health survey with 36 questions that yield eight health component scales that can be further summarized into two summary scores: mental and physical health scores. The eight health component scales that can be computed from the questionnaire are physical function, role-physical, bodily pain, general health, vitality, role-emotional, mental health and social functioning.	12 months

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Richard J Powell, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (ESTIMATE): February 10, 2011

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, Stenting
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: G100291