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New coil technique aims to stop dangerous leaks after aneurysm surgery

NCT ID NCT05665101

Prevention Sponsor: Univ.-Prof. Dr. Dr. med. Daniela Branzan Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 01, 2026 · Updated 3 times

Summary

This study tests whether adding metal coils to the aneurysm sac during standard endovascular repair (EVAR) can prevent type II endoleaks—a common complication where blood flows backward into the aneurysm. About 100 high-risk patients will be randomly assigned to receive EVAR alone or EVAR with coiling. The main goal is to see if coiling reduces endoleaks at 12 months.

What this could mean

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

Active substance
coil embolization (procedure)
What this could lead to
If successful, this could become a standard addition to EVAR for high-risk patients, reducing the need for invasive follow-up procedures.
What could go wrong
This is a relatively small, early-phase trial (100 participants) and the benefit may not apply to all patients. Coiling adds procedural time and carries its own risks, such as coil migration or incomplete sealing.

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

101 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Age ≥18 years * Infrarenal AAA ≥50 mm maximum diameter * Indication for EVAR within IFU of company * Presence of one or both high risk criteria on CT-A: ≥5 patent efferent vessels (inferior mesenteric and/or lumbar artery, and/or median sacral artery) or \<40% thrombus at largest AAA diameter Exclusion Criteria: * Ruptured AAA * Fenestrated or branched EVAR * Concomitant iliac artery aneurysm * Non-ability to adhere to the FU protocol * Lack of consent * Pregnancy

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm Endoleak

As listed by the trial registrant

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

Abdominal aortic aneurysm Endoleak

Contacts and locations

Locations

  • TUM Klinikum Rechts der Isar, Klinik und Poliklinik für Vaskuläre und Endovaskuläre Chirurgie

    Munich, Bavaria, 81675, Germany

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