New plug aims to seal aneurysm sac and prevent leaks
NCT ID NCT04227054
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.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2020
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Auckland City Hospital
Auckland, Auckland, 1023, New Zealand
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Waikato Hospital
Hamilton, 3240, New Zealand
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can sound waves replace CT scans for aortic aneurysm monitoring?
- Can a stent-graft keep aortic aneurysms in check for years? a long-term follow-up study aims to find out.
- Aneurysm repair may stiffen arteries — a study asks what that means for the heart
- Rehab after aneurysm surgery: could a 3-Week program boost heart and lung fitness?
- Nerve block may offer safer pain relief after major aortic surgery
- New device aims to seal aortic aneurysms without open surgery