Post-Approval Study of the Ovation™/Ovation Prime™ Abdominal Stent Graft System
This trial is active, not recruiting.
|Condition||aortic aneurysm, abdominal|
|Treatment||ovation™/ovation prime™ abdominal stent graft system|
|Start date||October 2013|
|End date||July 2020|
|Trial size||320 participants|
|Trial identifier||NCT01980901, 771-0010|
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.
Freedom From Aneurysm-Related Mortality at 5 Years
time frame: 5 Years
Composite Safety and Performance Endpoints
time frame: 1 Month & Annually 1 to 5 Years
Male or female participants at least 18 years old.
- 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.
- 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.
|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|
|Principal investigator||Syed Hussain, MD|
|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.|
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