Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
- Conditions
- Aortic Aneurysm, Abdominal
- Interventions
- Device: Ovation™/Ovation Prime™ Abdominal Stent Graft System
- Registration Number
- NCT01980901
- Lead Sponsor
- TriVascular, Inc.
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
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Patient is > 18 years of age.
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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).
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Patient has signed an Institutional Review Board (IRB) approved Informed Consent Form.
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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.
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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
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Patient has patent iliac or femoral arteries that allow endovascular access with the TriVascular Ovation/Ovation Prime Abdominal Stent Graft System.
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Patient has a suitable non-aneurysmal proximal aortic neck length of ≥ 7 mm inferior to the most distal renal artery ostium.
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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.
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Patient has a suitable non-aneurysmal proximal aortic neck luminal diameter between 16 and 30 mm.
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Patient has suitable non-aneurysmal distal iliac luminal diameters between 8 and 20 mm.
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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.
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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.
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Patient must be willing to comply with all required follow-up exams.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ovation™/Ovation Prime™ Abdominal Stent Graft System Ovation™/Ovation Prime™ Abdominal Stent Graft System Adult male and female patients.
- Primary Outcome Measures
Name Time Method Freedom From Aneurysm-Related Mortality at 5 Years 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.
- Secondary Outcome Measures
Name Time Method Composite Safety and Performance Endpoints 1 Month & Annually 1 to 5 Years 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
Trial Locations
- Locations (1)
Christie Clinical Vein and Vascular Center
🇺🇸Champaign, Illinois, United States