Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New plug may stop aneurysm leaks after surgery

NCT ID NCT04751578

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special plug can safely fill the leftover space inside an abdominal aortic aneurysm after standard stent repair. The goal is to prevent blood leaks (endoleaks) and help the aneurysm heal. Fifteen adults with large aneurysms will receive the plug during their scheduled repair and be monitored for complications and success.

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

15 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Apr 2027

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

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

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 * Aortoiliac aneurysm, or concomitant iliac artery ectasia or aneurysm (common iliac artery diameter \>24 mm) close to the bifurcation and/or that cannot be adequately sealed * Patent AAA sac feeding vessels (within the sac) \>4 mm in diameter * Volume of AAA sac to be filled after stent graft placement \<20 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, or Medtronic Endurant II Stent Graft 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Abdominal aortic aneurysm are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Dijklander Ziekenhuis

    Hoorn, North Holland, 1624 NP, Netherlands

  • ETZ Elisabeth

    Tilburg, Tilburg, 5022 GC, Netherlands

  • Rijnstate Hospital

    Arnhem, Gelderland, 6800 TA, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.