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: December 15, 2015
Last verified: December 2015
  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 (SFA) and Proximal Popliteal Arteries (PPA) 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:
  • Primary Safety Endpoint and Components [ Time Frame: 1 month for death, 12 months for target limb major amputation , and target lesion revascularization ] [ Designated as safety issue: Yes ]
    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

  • Co-Primary Efficacy Endpoints [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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).


Secondary Outcome Measures:
  • Secondary Safety Endpoint and Components [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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


Other Outcome Measures:
  • Technical and Procedural Success [ Time Frame: Up to 24 hours after the procedure ] [ Designated as safety issue: No ]
    • 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

  • Primary Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Assisted Primary Patency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Stent Fracture Rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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


  • Rutherford Classification [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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


  • Rate of Hemodynamic Improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.


  • Walking Improvement Assessed by the Walking Impairment Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Walking Improvement (Time) Assessed by 6 Minute Hall Walk [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessment of walking improvement 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.

  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Walking Improvement (Distance) Assessed by 6 Minute Hall Walk [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessment of walking improvement 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.


Enrollment: 299
Study Start Date: April 2011
Estimated Study Completion Date: July 2016
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

  Show 49 Study Locations
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
Results First Received: August 14, 2015
Last Updated: December 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, Stenting

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

ClinicalTrials.gov processed this record on February 09, 2016