Safety and Performance of Altura Endograft in Abdominal Aortic Aneurysm (AAA) Endovascular Repair

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the acute safety of deploying and implanting the Altura Endograft in the treatment of AAA in subjects who are candidates for endovascular repair. Secondary objectives are to evaluate the acute and longer-term safety and performance of the Altura Endograft through 5 years.

Detailed Description
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The primary safety endpoint of the study is freedom from Major Adverse Events (MAE), a composite endpoint consisting of death, stroke, paraplegia, myocardial infarction, respiratory failure, renal failure, bowel ischemia and blood loss ≥ 1000 mL.

Official Title
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ELEVATE International: Kissing Endografts for Peripheral AAA Exclusion

Conditions
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Abdominal Aortic Aneurysms

Intervention / Treatment
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* Device: Altura Endograft System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Understands and has signed an Informed Consent Candidate for endovascular or open surgical repair of an infrarenal aortic or aorto-iliac aneurysm Abdominal aneurysm > 45 mm or aneurysm growth of > 10 mm/year Abdominal aneurysm neck angulation ≤ 60 degrees Infrarenal non-aneurysmal neck 15 mm Infrarenal non-aneurysmal neck diameter between 18 and 28 mm, inclusive Iliac artery landing zone 15 mm in length Iliac artery landing zone diameter between 8 and 18 mm, inclusive Patent iliac and femoral arteries, access vessels, size and morphology, to allow endovascular access of a minimum 14 Fr introducer sheath and catheter Ability to preserve at least one hypogastric artery Life expectancy > one year American Society of Anesthesiology (ASA) grade 1 through 3, inclusive Able and willing to comply with follow-up visits at 30 days, 6 and 12 months and annually through 5 years Exclusion Criteria: Pregnant or nursing An acutely ruptured, leaking or emergent aneurysm An aortic dissection (Type A or B) A mycotic, infected or inflammatory aneurysm A thoracic, suprarenal or juxtarenal aneurysm Previous surgical or endovascular aneurysm repair for abdominal aortic aneurysm or an aorto-iliac aneurysm Severe iliac artery tortuosity Thrombus, calcification and/or plaque that may complicate sealing Evidence or history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the past 3 months Current angina or other active cardiac condition such as congestive heart failure, untreated or worsening atrial arrhythmia, ventricular arrhythmia or valvular disease Had or plans to have an unrelated major surgical or interventional procedure within 1 month before or after implantation of the study device Significant (>80%) diameter renal artery stenosis which could not be readily treated Known sensitivity or allergy to nitinol or polyester Known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment Contraindication to antiplatelet, anticoagulant or thrombolytic therapy; Coagulopathy or uncontrolled bleeding disorder History of heparin-induced thrombocytopenia (HIT) Clinically and morbidly obese such that the required imaging would be prevented Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndromes) Currently on dialysis or has compromised renal function as reflected by a serum creatinine >2.0 mg/dL Compromised hepatic function Active infection at the time of the index procedure End-stage chronic obstructive pulmonary disorder (COPD) Religious, cultural or other objections to the receipt of blood or blood products Participating in another research study involving an investigational device or drug which may potentially affect study results Other medical, social or psychological problems that, in the opinion of the Investigator, preclude them from receiving this treatment and the procedures and evaluations pre- and post-treatment

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AAA<br>Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm will be treated with the Altura Endograft System. | Device: Altura Endograft System<br>* Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Endpoint | Freedom from Major Adverse Events (MAE), a composite endpoint consisting of: Death Stroke Paraplegia Myocardial infarction Respiratory failure Renal failure Bowel ischemia Blood loss ≥ 1000 mL | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Endpoint | Major Adverse Events (MAE) Aneurysm-related death Type I and III endoleaks AAA rupture Re-intervention to correct Type I or Type III endoleaks, migration, occlusion, narrowing, stenosis, kinking or fracture | 30 days, 6 and 12 months and annually through 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AAA, Abdominal Aortic Aneurysms