Clinical trial NCT04751578: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Shape Memory Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-12
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of related major adverse events (MAEs)
timeFrame: 30 days post-procedure
measure: Efficacy - Technical Success
timeFrame: Immediately after the intervention
Secondary outcomes:
measure: Incidence of related major adverse events (MAEs)
timeFrame: 2 years post-procedure
measure: Incidence of related serious adverse events (SAEs)
timeFrame: 2 years post-procedure
measure: Efficacy - Type II endoleaks
timeFrame: 2 years post-procedure
measure: Efficacy - Type I and type III endoleaks
timeFrame: 2 years post-procedure
measure: Efficacy - AAA sac diameter/volume
timeFrame: 2 years post-procedure
measure: Efficacy - Open repair
timeFrame: 2 years post-procedure
measure: Efficacy - Reinterventions
timeFrame: 2 years post-procedure
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
state: Noord-Holland
city: Tilburg
country: Netherlands
facility: ETZ Elisabeth
Study officials:
References: