Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands (AAA-SHAPE_NLD)

Shape Memory Medical

Status

Active, not recruiting

Conditions

Abdominal Aortic Aneurysm

Treatments

Device: IMPEDE-FX Embolization Plug

Study type

Interventional

Funder types

Industry

Identifiers

NCT04751578

CRD1020

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.