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Tailored stents show promise for Hard-to-Treat aneurysms

NCT ID NCT03295682

Disease control Sponsor: JOTEC GmbH 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 47 people with thoracoabdominal aortic aneurysms (a bulge in the main artery in the chest and belly). They received a custom-made stent graft (a fabric-covered metal tube) designed to fit their unique anatomy. The goal was to see if the aneurysm size stayed stable or shrank one year after the procedure. The approach aims to offer a treatment option for aneurysms that standard devices can't fix.

What this could mean

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

Active substance
multi-branch stent graft
What this could lead to
If successful, this could offer a safe, personalized treatment option for complex aortic aneurysms that can't be treated with standard devices.
What could go wrong
This is a small, completed registry (47 patients) without a control group, so results may not apply to everyone. Risks include device-related complications or aneurysm rupture.

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.

Participants

47 people

The number who actually took part.

Started

Sep 2017

Finished

Aug 2024

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.

Who is studied

A total number of 40 male and female patients with asymptomatic thoracoabdominal aortic aneurysm, treated with a multi-branch stent graft system.

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 * Patients must have a thoracoabdominal aneurysm type Crawford type I, II, III, IV, or V * Patients must have a suitable proximal landing area * Patients must have a suitable distal landing area in the abdominal aorta or the iliac arteries * Patients must have suitable access vessels * Patients must be available for the appropriate follow-up times for the duration of the study * Patients have signed the informed consent before intervention Exclusion Criteria: * Patients with infectious aneurysm * Patients with inflammatory aneurysm * Patients with ruptured or symptomatic aneurysm * Patients with traumatic aneurysm * Patients with aortic dissection * Patients who have a congenital degenerative collagen disease or connective tissue disorder * Patients with thrombocytopenia * Patients with an eGFR \< 45ml/min/1.73m2 before the intervention * Patients with untreated hyperthyroidism * Patients with malignancy needing chemotherapy or radiation * Patients that will be treated or are treated with iliac branch devices * Patients pre-treated with Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) stent grafts * Patients who are enrolled in another clinical study * Patients with life expectancy of less than 36 months

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Conditions

The condition(s) this trial relates to.

aortic aneurysm thoracic aortic aneurysm

As listed by the trial registrant

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

Thoracoabdominal aneurysm

Contacts and locations

Locations

  • Uniklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225, Germany

More trials for these conditions

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