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: August 26, 2014
Last verified: August 2014
  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
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
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 21, 2014