Clinical Study of the TriVascular Ovation™ Abdominal Stent Graft System

Study Overview
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Brief Summary
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The primary objectives of this study are to determine whether the Ovation Abdominal Stent Graft System is a safe and effective method of treating abdominal aortic aneurysms (AAA's) in those patients considered to be suitable candidates for open surgical repair.

Detailed Description
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This is a Phase II prospective, consecutive enrolling, non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA (Treatment Group) as compared to a performance goal (Control Group). 150 study patients will be enrolled at up to 40 institutions. An additional 100 study patients will be enrolled in the continued access phase.

Official Title
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A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation™ Abdominal Stent Graft System

Conditions
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Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Device: Ovation™ Abdominal Stent Graft System


Participation Criteria
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Eligibility Criteria
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Inclusion/Exclusion Criteria: Inclusion Criteria All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study: 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 abdominal aortic aneurysm (AAA) (i.e., category I, II, or III per American Society of Anesthesiology (ASA) classification. 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 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. Exclusion Criteria Patients that meet ANY of the following are not eligible for enrollment into the study: 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 another 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ovation™ Abdominal Stent Graft System<br>Implant of Ovation™ Abdominal Stent Graft System | Device: Ovation™ Abdominal Stent Graft System<br>* Implant of Ovation™ Abdominal Stent Graft System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Safety Endpoint is Defined as the Percentage of Subjects Who Experience a Major Adverse Event Within 30 Days of the Initial Procedure. | Major adverse events (MAE) are defined as any one of the following events: Death Myocardial Infarction Stroke (excludes TIA) Renal Failure (excludes renal insufficiency) Respiratory Failure (excludes COPD or pulmonary complications) Paralysis (excludes paraparesis) Bowel Ischemia Procedural Blood Loss (≥1,000 cc) | 30 days | 
| The Primary Effectiveness Endpoint is Percentage of Subjects That Achieve Treatment Success. | Treatment Success is a composite endpoint assessed at 12 months that requires the following criteria to be met: Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs. Freedom from Type I & III endoleaks at 12 months Freedom from stent graft migration at 12 months Freedom from abdominal aortic aneurysm (AAA) enlargement at 12 months Freedom from abdominal aortic aneurysm (AAA) rupture and conversion to open repair through 12 months Endoleak Definition: Type I - Ineffective seal at either the proximal or distal sealing zones Type II - Retrograde blood flow from lumbar arteries, the inferior mesenteric artery, or other collateral vessels into the aneurysm sac Type III - A leak caused by fabric tears or disruption, component disconnection, or graft disintegration Type IV - Blood flow through an intact fabric. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal, aortic, aneurysm