Abdominal Aortic Aneurysm
Conditions
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.
Interventions
Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft
Sponsors
Shape Memory Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of related major adverse events (MAEs) | 30 days post-procedure | Incidence of related major adverse events (MAEs) |
| Efficacy - Technical Success | Immediately after the intervention | Technical success, defined as filling of the residual flow lumen of the AAA sac with investigational products |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Type II endoleaks | 5 years post-procedure | Incidence of type II endoleaks |
| Efficacy - Type I and type III endoleaks | 5 years post-procedure | Incidence of type I and type III endoleaks |
| Incidence of related major adverse events (MAEs) | 5 years post-procedure | Incidence of related major adverse events (MAEs) |
| Efficacy - Open repair | 5 years post-procedure | Rate of conversion to open AAA repair |
| Efficacy - Reinterventions | 5 years post-procedure | Rate of other reinterventions related to the AAA sac growth and/or complications |
| Efficacy - AAA sac diameter/volume | 5 years post-procedure | Change in AAA sac diameter/volume |
| Incidence of related serious adverse events (SAEs) | 5 years post-procedure | Incidence of related serious adverse events (SAEs) |
Countries
Netherlands
Outcome results
None listed