Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - Netherlands
Not Applicable
- Conditions
- Abdominal Aortic Aneurysm
- Interventions
- Device: IMPEDE-FX Embolization Plug
- Registration Number
- NCT04751578
- Lead Sponsor
- Shape Memory Medical, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention IMPEDE-FX Embolization Plug -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Incidence of related major adverse events (MAEs) 2 years post-procedure Incidence of related major adverse events (MAEs)
Incidence of related serious adverse events (SAEs) 2 years post-procedure Incidence of related serious adverse events (SAEs)
Efficacy - Type II endoleaks 2 years post-procedure Incidence of type II endoleaks
Efficacy - Type I and type III endoleaks 2 years post-procedure Incidence of type I and type III endoleaks
Efficacy - AAA sac diameter/volume 2 years post-procedure Change in AAA sac diameter/volume
Efficacy - Open repair 2 years post-procedure Rate of conversion to open AAA repair
Efficacy - Reinterventions 2 years post-procedure Rate of other reinterventions related to the AAA sac growth and/or complications
Trial Locations
- Locations (3)
ETZ Elisabeth
🇳🇱Tilburg, Netherlands
Rijnstate Hospital
🇳🇱Arnhem, Gelderland, Netherlands
Dijklander Ziekenhuis
🇳🇱Hoorn, Noord-Holland, Netherlands