Status:
ACTIVE_NOT_RECRUITING
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands
Lead Sponsor:
Shape Memory Medical, Inc.
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
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 g...
Eligibility Criteria
Inclusion
- ≥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
- 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.
Key Trial Info
Start Date :
July 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04751578
Start Date
July 13 2021
End Date
April 30 2027
Last Update
December 22 2025
Active Locations (3)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6800 TA
2
Dijklander Ziekenhuis
Hoorn, North Holland, Netherlands, 1624 NP
3
ETZ Elisabeth
Tilburg, Tilburg, Netherlands, 5022 GC