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Abdominal Aortic AneurysmAAA-SHAPENCT04227054

Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks

A study testing IMPEDE-FX Embolization Plug in people with Abdominal Aortic Aneurysm, run by Shape Memory Medical, Inc. at 2 sites in New Zealand.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Abdominal Aortic Aneurysm
What is being tested?
IMPEDE-FX Embolization Plug
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesNew Zealand
Study dates
9 Sep 2020to 30 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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
Show all 27Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

New Zealand2 sites

  • Auckland City Hospital

    Auckland, Auckland, 1023

  • Waikato Hospital

    Hamilton, 3240

Other trials in New Zealand

About this study

Official title: Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks - A Prospective Single Center Safety Study

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.

Being tested
IMPEDE-FX Embolization Plug
Medical subject headings
Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMPEDE-FX Embolization PlugDevice

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

Study groups in NCT04227054
Study groupRoleWhat they receive
InterventionExperimentalNot described
Receives: Device: IMPEDE-FX Embolization Plug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of related major adverse events (MAEs)

    Incidence of related major adverse events (MAEs)

    Measured: 30 days post-procedure

  2. Efficacy - Technical Success

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

    Measured: Immediately after the intervention

Secondary outcomes (7)

  1. Incidence of related major adverse events (MAEs)

    Incidence of related major adverse events (MAEs)

    Measured: 5 years post-procedure

  2. Incidence of related serious adverse events (SAEs)

    Incidence of related serious adverse events (SAEs)

    Measured: 5 years post-procedure

  3. Efficacy - Type II endoleaks

    Incidence of type II endoleaks

    Measured: 5 years post-procedure

  4. Efficacy - Type I and type III endoleaks

    Incidence of type I and type III endoleaks

    Measured: 5 years post-procedure

  5. Efficacy - AAA sac diameter/volume

    Change in AAA sac diameter/volume

    Measured: 5 years post-procedure

  6. Efficacy - Open repair

    Rate of conversion to open AAA repair

    Measured: 5 years post-procedure

  7. Efficacy - Reinterventions

    Rate of other reinterventions related to the AAA sac growth and/or complications

    Measured: 5 years post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start9 Sep 2020
  3. Primary completion30 Aug 2023
  4. Study completion30 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04227054
Sponsor's protocol ID
CRD1015
Acronym
AAA-SHAPE
Status last verified
Dec 2025
First submitted
10 Jan 2020
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing IMPEDE-FX Embolization Plug in people with Abdominal Aortic Aneurysm, run by Shape Memory Medical, Inc. at 2 sites in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of related major adverse events (MAEs) (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04227054.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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