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

NCT01980901 | Completed DMC

• 1 other identifier: 771-0010
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aortic Aneurysm, Abdominal

Keywords

AAA

Outcome Measures

Primary Outcomes (1)

• Freedom From Aneurysm-Related Mortality at 5 Years

  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.

  5 Years

Secondary Outcomes (1)

• Composite Safety and Performance Endpoints

  1 Month & Annually 1 to 5 Years

Study Arms (1)

Ovation™/Ovation Prime™ Abdominal Stent Graft System

Adult male and female patients.

Device: Ovation™/Ovation Prime™ Abdominal Stent Graft System

Interventions

Ovation™/Ovation Prime™ Abdominal Stent Graft System DEVICE

Single occurence permanent implant of AAA device.

Ovation™/Ovation Prime™ Abdominal Stent Graft System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient is \> 18 years of age.
• 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).
• Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form.
• 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.
• 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
• Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation/Ovation Prime Abdominal Stent Graft System.
• Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
• 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.
• Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
• Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm.
• 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.
• 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.

You may not qualify if:

• Patient has a dissecting aneurysm.
• Patient has an acutely ruptured aneurysm.
• Patient has an acute vascular injury.
• Patient has a need for emergent surgery.
• Patient has a known thoracic aortic aneurysm or dissection.
• Patient has a mycotic aneurysm or has an active systemic infection.
• 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).
• Patient has had a myocardial infarction (MI) and/or stroke (CVA) within the past 6 months.
• Patient has a major surgical or interventional procedure planned ≤30 days of the AAA repair.
• Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
• Patient has history of bleeding disorders or refuses blood transfusions.
• Patient has dialysis dependent renal failure or baseline serum creatinine level \>2.0 mg/dl
• Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
• Patient has a known allergy or intolerance to polytetrafluoroethylene (PTFE), PEG-based polymers, fluorinated ethylene propylene (FEP) or nitinol.
• Patient has a body habitus that would inhibit X-ray visualization of the aorta

Sponsors & Collaborators

• TriVascular, Inc.: lead

Study Sites (1)

Christie Clinical Vein and Vascular Center

Champaign, Illinois, 61820, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Syed Hussain, MD

  Christie Clinical Vein and Vascular Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: October 1, 2013
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: June 4, 2021

Record last verified: 2021-06

Locations

US (1)