Clinical Study of the TriVascular Ovation Abdominal Stent Graft System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.
ClinicalTrials.gov Identifier:
NCT01092117
First received: March 17, 2010
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

The primary objectives of this study are to determine whether the Ovation Abdominal Stent Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patients considered to be suitable candidates for open surgical repair.


Condition Intervention Phase
Aortic Aneurysm, Abdominal
Device: Endovascular Implant of Ovation Abdominal Stent Graft System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation Abdominal Stent Graft System

Resource links provided by NLM:


Further study details as provided by TriVascular, Inc.:

Primary Outcome Measures:
  • The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event within 30 days of the initial procedure. The primary effectiveness endpoint is proportion of subjects that achieve Treatment Success. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Composite Safety and Effectiveness Endpoints [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]

    The secondary safety endpoints are:

    • Mortality rates at 30 days and 12 months
    • AAA related mortality at 30 days and 12 months
    • Major Adverse Events (MAE) through 12 months
    • AAA rupture through 12 months
    • Conversion to open repair through 12 months

    The secondary effectiveness endpoints will be evaluated through 12 months:

    • Technical success, defined as successful delivery and deployment of one aortic body and two iliac limbs.
    • Freedom from Type I & III endoleaks
    • Freedom from stent graft migration
    • Freedom from AAA enlargement
    • Freedom from loss of device integrity

    The secondary Clinical Utility endpoints will be evaluated:

    • Blood loss
    • Duration of procedure
    • Length of hospital stay
    • Type of anesthesia
    • Type of vascular access


Estimated Enrollment: 150
Study Start Date: March 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endovascular Implant of Ovation Abdominal Stent Graft System
    Endovascular repair of AAA involving the placement of a stent graft at the location of the aneurysm without the need for performing an open surgical procedure.
Detailed Description:

This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA (Treatment Group) as compared to a performance goal (Control Group).

150 study patients will be enrolled at up to 40 institutions. An additional 100 study patients will be enrolled in the continued access phase.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion Criteria:

Inclusion Criteria

All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:

  1. Patient is > 18 years of age
  2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
  3. Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form
  4. Patient is considered by the treating physician to be a candidate for elective open surgical repair of the AAA (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification. ASA category IV patients may be enrolled provided their life expectancy is greater than 1 year.
  5. Patient has an infrarenal abdominal aortic aneurysm that meets at least one of the following:

    • Abdominal aortic aneurysm ≥5.0 cm in diameter
    • Aneurysm has increased in size by 0.5 cm in last 6 months.
    • Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment
  6. Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation Abdominal Stent Graft System.
  7. Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
  8. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of ≥10 mm. The resultant repair should preserve patency in at least one hypogastric artery.
  9. Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
  10. Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm.
  11. Patient meets the following anatomic criteria: the distance from the most distal renal artery to most superior internal iliac artery measurement is at least 13 cm.
  12. Patient has juxtarenal aortic neck angulation ≤ 60º if proximal neck is ≥10 mm and ≤ 45º if proximal neck is <10 mm.
  13. Patient must be willing to comply with all required follow-up exams.

Exclusion Criteria

Patients that meet ANY of the following are not eligible for enrollment into the study:

  1. Patient has a dissecting aneurysm
  2. Patient has an acutely ruptured aneurysm
  3. Patient has an acute vascular injury
  4. Patient has a need for emergent surgery
  5. Patient has a known thoracic aortic aneurysm or dissection.
  6. Patient has a mycotic aneurysm or has an active systemic infection
  7. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
  8. Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
  9. Patient has a major surgical or interventional procedure planned ≤30 days of the AAA repair.
  10. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
  11. Patient has history of bleeding disorders or refuses blood transfusions.
  12. Patient has dialysis dependent renal failure or baseline serum creatinine level >2.0 mg/dl
  13. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
  14. Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol.
  15. Patient has a body habitus that would inhibit X-ray visualization of the aorta
  16. Patient has a limited life expectancy of less than 1 year
  17. Patient is currently participating in another investigational device or drug clinical trial
  18. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
  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: NCT01092117

Locations
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
Sponsors and Collaborators
TriVascular, Inc.
Investigators
Principal Investigator: Manish Mehta, MD Albany Medical College
  More Information

Additional Information:
No publications provided by TriVascular, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT01092117     History of Changes
Other Study ID Numbers: 771-0006
Study First Received: March 17, 2010
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on August 20, 2014