Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by TriVascular, Inc.
Sponsor:
Information provided by (Responsible Party):
TriVascular, Inc.
ClinicalTrials.gov Identifier:
NCT01980901
First received: November 4, 2013
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

The Post-Approval Study (PAS) will evaluate the "real world" data on the Ovation™/Ovation Prime™ Abdominal Stent Graft System along with the long-term data collected from the IDE cohort to monitor the long-term safety and effectiveness of the device.


Condition Intervention
Aortic Aneurysm, Abdominal
Device: Ovation™/Ovation Prime™ Abdominal Stent Graft System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post-Market Approved (PMA) Post-Approval Study to Evaluate the Long-Term Safety and Effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System

Resource links provided by NLM:


Further study details as provided by TriVascular, Inc.:

Primary Outcome Measures:
  • Freedom From Aneurysm-Related Mortality at 5 Years [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
    The primary endpoint of the Ovation™/Ovation Prime™ Abdominal Stent Graft System study will be determined by evaluating freedom from aneurysm-related mortality at five (5) years. This will be compared to a target performance goal.


Secondary Outcome Measures:
  • Composite Safety and Performance Endpoints [ Time Frame: 1 Month & Annually 1 to 5 Years ] [ Designated as safety issue: Yes ]

    Serious Adverse Events (SAEs) within 30 days of the initial procedure and through 12 months and annually thereafter to 5 years

    At 30 days and 12 months and annually thereafter to 5 years, the following rates will be reported:

    • Mortality (AAA-related and all-cause)
    • Device patency
    • Conversion to open surgical repair
    • Endoleak
    • AAA enlargement
    • Stent Graft Migration
    • Device integrity
    • Secondary endovascular procedures
    • Aneurysm rupture


Estimated Enrollment: 320
Study Start Date: October 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ovation™/Ovation Prime™ Abdominal Stent Graft System
Adult male and female patients will be consecutively screened for the study. Eligible patients must meet all of the inclusion criteria and none of the exclusion criteria.
Device: Ovation™/Ovation Prime™ Abdominal Stent Graft System
Single occurence permanent implant of AAA device.

Detailed Description:

The purpose of the study is to demonstrate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment.

The clinical objective of the study is to evaluate the long term safety and effectiveness of the Ovation™/Ovation Prime™ Abdominal Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality.

Additionally, this study will evaluate the physician training program for modifications based on IDE and post-approval experience.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

320 subjects enrolled with an estimated 192 evaluable subjects at the fifth year from the following cohorts:

  • Available data from the 161 pivotal cohort subjects
  • All Continued Access subjects;
  • All subjects from the HDE PAS (reference H100008); and
  • A minimum of 59 subjects from de novo enrollment.
Criteria

Inclusion Criteria:

  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; refer to Appendix III: ASA Classification System). 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/Ovation Prime 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. Patient must be willing to comply with all required follow-up exams.
  13. Patient must be willing to comply with all required follow-up exams.

Exclusion Criteria:

  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 an 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: NCT01980901

Contacts
Contact: Shari O'Quinn 707-543-8807 soquinn@trivascular.com

Locations
United States, Illinois
Christie Clinical Vein and Vascular Center Recruiting
Champaign, Illinois, United States, 61820
Principal Investigator: Syed Hussain, MD         
Sponsors and Collaborators
TriVascular, Inc.
Investigators
Principal Investigator: Syed Hussain, MD Christie Clinical Vein and Vascular Center
  More Information

Additional Information:
No publications provided

Responsible Party: TriVascular, Inc.
ClinicalTrials.gov Identifier: NCT01980901     History of Changes
Other Study ID Numbers: 771-0010
Study First Received: November 4, 2013
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by TriVascular, Inc.:
AAA

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

ClinicalTrials.gov processed this record on July 24, 2014