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

Completed

Conditions studied: Aortic Aneurysm, Abdominal

In brief

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.

Key facts

Study ID

NCT01980901

Run by

TriVascular, Inc.

People needed

320

Starts

2013-10-01

Expected to finish

2020-09-01

Last updated by the study team

2021-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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
• Patient has a limited life expectancy of less than 1 year
• Patient is currently participating in an investigational device or drug clinical trial.
• 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.

Where it is running

• Christie Clinical Vein and Vascular Center — Champaign, Illinois, United States

Full record on ClinicalTrials.gov

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