New plug aims to seal aneurysm sac and prevent leaks

NCT ID NCT04227054

Ongoing Disease control Sponsor: Shape Memory Medical, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a device called IMPEDE-FX that is used to fill the empty space around a stent graft after standard abdominal aortic aneurysm repair. The goal is to see if it is safe and can prevent blood from leaking into the aneurysm sac. The trial involves 15 adults who are already scheduled for elective aneurysm repair.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: IMPEDE-FX Embolization Plug and IMPEDE-FX Rapid Fill (device to fill the aneurysm sac)
What this could lead to: If successful, this device could reduce the risk of internal leaks after standard aneurysm repair, potentially improving long-term outcomes.
What could go wrong: This is a very small, early safety study with only 15 participants, so results may not apply to everyone. The device may not prevent leaks or could cause complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ABDOMINAL AORTIC ANEURYSM

Contacts and locations

Locations

Auckland City Hospital

Auckland, Auckland, 1023, New Zealand
Waikato Hospital

Hamilton, 3240, New Zealand

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