Brief Title
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands
Official Title
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Multicenter Study
Brief 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.
Study Type
Interventional
Primary Outcome
Incidence of related major adverse events (MAEs)
Secondary Outcome
Incidence of related major adverse events (MAEs)
Condition
Abdominal Aortic Aneurysm
Intervention
IMPEDE-FX Embolization Plug
Study Arms / Comparison Groups
Intervention
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
15
Start Date
July 13, 2021
Completion Date
July 1, 2024
Primary Completion Date
April 13, 2022
Eligibility Criteria
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 - Aortoiliac aneurysm, or concomitant iliac artery ectasia or aneurysm (common iliac artery diameter >24 mm) close to the bifurcation and/or that cannot be adequately sealed - Patent AAA sac feeding vessels (within the sac) >4 mm in diameter - Volume of AAA sac to be filled after stent graft placement <20 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, or Medtronic Endurant II Stent Graft 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 aorta - Coagulopathy or uncontrolled bleeding disorder - Long-term (>6 months prior to the procedure) use of direct oral anticoagulant or any vitamin K antagonist anticoagulant use - 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 - Unable or unwilling to comply with study follow-up requirements - Life expectancy of <2 years post-procedure - Known hypersensitivity or contraindication to platinum, iridium, or polyurethane - A condition that inhibits radiographic visualization during the implantation procedure - History of allergy to contrast medium that cannot be managed medically - Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the study - Pregnant or a 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 study - Prisoner or member of other vulnerable population.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT04751578
Organization ID
CRD1020
Responsible Party
Sponsor
Study Sponsor
Shape Memory Medical, Inc.
Study Sponsor
, ,
Verification Date
May 2022