Clinical trial NCT04227054: Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
Official title: Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Single Center Safety Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Shape Memory Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-13
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
* Concomitant iliac artery ectasia or aneurysm (common iliac artery diameter \>24 mm)
* Patent AAA sac feeding vessels (within the sac) \>4 mm in diameter
* Volume of AAA sac to be filled after stent graft placement \<30 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, Medtronic Endurant II Stent Graft, or Endologix Ovation Alto Abdominal Stent Graft System 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: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
References: