TriVascular European Union (EU) Abdominal Stent Graft Trial

Study Overview
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Brief Summary
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A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System

Detailed Description
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A prospective, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and performance of the TriVascular AAA Stent Graft when used in the treatment of patients with Abdominal Aortic Aneurysms (AAA).

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

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: Implant of Ovation Abdominal Stent Graft System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Ethics Committee (EC) 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 AAA device. 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: 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 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: Implant of Ovation Abdominal Stent Graft System<br>* Single occurrence permanent implant of AAA device.<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 proportion of subjects who experience a Serious Adverse Event within 30 days of the initial procedure. | The safety of the TriVascular AAA Stent Graft will be determined by comparing the rate of Serious Adverse Events in the Treatment Group against the rate of Serious Adverse Events in the Control Group within 30 days of the initial procedure. | 30-Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the performance of the TriVascular AAA Stent-Graft System within 30 days of the initial procedure. | The performance of the TriVascular AAA Stent-Graft System will be determined by comparing the composite success rate in the Treatment Group against an estimated success rate of 80% in the Control Group within 30 days of the initial procedure. The composite success rate is defined as: Technical Success, defined as successful delivery and deployment of one aortic body and two iliac limbs. Absence of Type I and III endoleaks Absence of Rupture Absence of Conversion to Open Surgical Repair Freedom from mortality | 30-Days | 

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