Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks

NCT04227054 | Active Not Recruiting FDA Device

• 1 other identifier: CRD1015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (2)

• Incidence of related major adverse events (MAEs)

  Incidence of related major adverse events (MAEs)

  30 days post-procedure

• Efficacy - Technical Success

  Technical success, defined as filling of the residual flow lumen of the AAA sac with investigational products

  Immediately after the intervention

Secondary Outcomes (7)

• Incidence of related major adverse events (MAEs)

  5 years post-procedure

• Incidence of related serious adverse events (SAEs)

  5 years post-procedure

• Efficacy - Type II endoleaks

  5 years post-procedure

• Efficacy - Type I and type III endoleaks

  5 years post-procedure

• Efficacy - AAA sac diameter/volume

  5 years post-procedure

Study Arms (1)

Intervention

EXPERIMENTAL

Device: IMPEDE-FX Embolization Plug

Interventions

IMPEDE-FX Embolization Plug DEVICE

Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shape Memory Medical, Inc.: lead

Study Sites (2)

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 13, 2020
• Study Start: September 9, 2020
• Primary Completion: August 30, 2023
• Study Completion (Estimated): August 30, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)