AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Study Overview
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Brief Summary
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To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.

Official Title
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AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

Conditions
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Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Device: IMPEDE-FX RapidFill Implants
* Procedure: EndoVascular Aneurysm Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women; Thrombus burden (percentage of the AAA sac occupied by thrombus) <50%, based on pre-procedure CTA Maximum Lumen diameter within the AAA sac of ≥40mm. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200. Exclusion Criteria: General An inability to provide informed consent. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial. Unable or unwilling to comply with study follow-up requirements. Prisoner or member of other vulnerable population Anatomical Concomitant iliac artery ectasia or aneurysm Vascular disease and/or anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm. Connective tissue disorder (e.g., Marfan's syndrome) Aneurysmal disease of the descending thoracic aorta Excessive calcification at the aortic bifurcation to common/internal iliac bifurcation, that might lead to access difficulties EVAR/Procedural Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA Use of an aortic stent graft other than those specified1 for a particular site Planned use of the chosen stent graft outside its instructions for use (IFU) Use of fenestrated stent grafts or chimney techniques Use of the Heli-FX EndoAnchor system Use of embolic devices other than the investigational product to embolize the AAA sac Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries Medical History/Conditions Coagulopathy or uncontrolled bleeding disorder Serum creatinine level >2.5 mg/dL Cerebrovascular accident within 3 months prior to the procedure Myocardial infarction and/or major heart surgery within 3 months prior to the procedure Atrial fibrillation that is not well rate controlled Life expectancy of <2 years post-procedure Known hypersensitivity or contraindication to platinum, iridium, or polyurethane. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC >11,000/mm3) A condition that inhibits radiographic visualization during the implantation procedure History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, multicenter, randomized, open-label trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Treatment Arm: Subjects in the treatment arm will have both an EVAR device and IMPEDE-FX RapidFill implants inserted. | Device: IMPEDE-FX RapidFill Implants<br>* Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants<br>Procedure: EndoVascular Aneurysm Repair<br>* Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.<br>* Other names: EVAR;|
| Active Comparator: Control<br>Control Arm: Subjects in the control arm will only have an EVAR device implanted. | Procedure: EndoVascular Aneurysm Repair<br>* Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.<br>* Other names: EVAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year, and no AAA-related intervention through 1 year. | 1 year | 
| Primary Safety Endpoint | Freedom from the following through 30 days post-index procedure: Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss >1000 mL. AAA-rupture or AAA-perforation Conversion to Open Repair | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal Aortic Aneurysm