Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks (NCT04227054) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
New Zealand15 participantsStarted 2020-09-09
Plain-language summary
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* ≥18 years of age
* A candidate for elective EVAR of an infrarenal aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women
Exclusion Criteria:
* An inability to provide informed consent
* Enrolled in another clinical study
* Concomitant iliac artery ectasia or aneurysm (common iliac artery diameter \>24 mm)
* Patent AAA sac feeding vessels (within the sac) \>4 mm in diameter
* Volume of AAA sac to be filled after stent graft placement \<30 mL or \>135 mL, based on pre-procedure CTA (i.e. aortic flow volume exclusive of stent graft volume)
* Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II Stent Graft, or Endologix Ovation Alto Abdominal Stent Graft System to treat the AAA
* Planned use of the chosen stent graft outside its instructions for use (IFU)
* Planned use of fenestrated or chimney stent grafts
* Study participants in which stent graft placement is abandoned for any reason, and/or in which the investigator decides, during the course of the stent graft placement, that the study procedure may not be appropriate
* Planned use of embolic devices other than the investigational product to embolize the AAA sac
* 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, or mycotic (infected) aneurysm
* Aneurysmal disease of the descending thoracic …