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

Gå till den engelska sidan

New stent device aims to fix dangerous aortic bulge without major surgery

NCT ID NCT06710938

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study is testing a new stent graft system designed to treat thoracoabdominal aortic aneurysms, a dangerous bulge in the main artery that runs through the chest and belly. The device has special branches to keep blood flowing to vital organs. Researchers will enroll 11 people to see if the device can be safely placed and works as intended, with follow-up for a year.

What this could mean

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

Active substance
thoracoabdominal artery stent graft system (a device with branches for key arteries)
What this could lead to
If successful, this could offer a less invasive treatment option for a complex type of aortic aneurysm, potentially reducing the need for open surgery.
What could go wrong
This is a very small, early exploratory study with only 11 people. The device may fail to work as intended, and there are serious risks like stroke, paralysis, or death.

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 11 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2032

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 to 80 years

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: 1. Age: 18 to 80 years old; 2. Patients diagnosed with a Thoracoabdominal aortic aneurysm (based on the modified Crawford classification and European Society for Vascular Surgery (ESVS) 2019 Clinical Practice Guidelines on the Management of Abdominal Aorto-iliac Artery Aneurysms), and should meet at least ONE of the following conditions: 1. Maximum diameter of TAAA is \>50 mm; 2. TAAA diameter increases by more than 5 mm in the past 6 months or by more than 10 mm in the past 1 year; 3. Definite symptoms associated with TAAA, such as abdominal pain and back pain. 3. Anatomical Criteria 1. Proximal landing zone (aorta or implanted graft): the diameter ranges from 17 to 36 mm, and length should be ≥25 mm; 2. Distal landing zone (aorta or implanted graft): If distal landing zone is in iliac artery, distal landing zone diameter ranges from 7 to 25 mm, and length should be ≥15 mm; If the distal landing zone is in the abdominal aorta, distal landing zone diameter ranges from 12 to 36 mm, and length should be ≥20 mm. 3. Visceral branch landing zone: the diameter ranges from 6 to 13 mm, and the length should be ≥15 mm; 4. Renal artery landing zone: the diameter ranges from 4.5 to 9 mm, and the length should be ≥15 mm; 5. Appropriate iliac, femoral, and upper limb arterial access. 4. Patients who understand the purpose of the study, volunteer to participate and sign the informed consent form, and are willing to complete follow-up as required by the protocol; 5. Patients do not want to or cannot wait for the approved alternative Exclusion Criteria: Exclusion Criteria (not eligible if any of the criteria is met): 1. Patients with ruptured thoracoabdominal aortic aneurysms in unstable hemodynamic condition; 2. Patients with thoracoabdominal aortic dissection; 3. Patients with infected or mycotic thoracoabdominal aortic aneurysms; 4. Patients with systemic or local infections that may increase the risk of endovascular graft infection; 5. Patients with occluded superior mesenteric artery, celiac trunk artery, or renal artery; 6. Patients requiring simultaneous coverage or embolization of bilateral internal iliac arteries; 7. Patients with severe stenosis, calcification or mural thrombus at stent-graft landing zone, and this situation leads to difficulty in adhering the covered stent or affecting the patency of the stent; 8. Patients with a history of acute coronary syndrome within the recent 6 months; Acute coronary syndrome refers to acute cardiac ischemic syndrome caused by rupture or erosion of unstable atherosclerotic plaques in the coronary artery and fresh thrombosis, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris. 9. Patients with transient ischemic attack (TIA) or ischemic/hemorrhagic stroke within the recent 3 months; 10. Patients with abnormal liver and kidney function before operation \[alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal value; Serum creatinine (Cr) \>150umol/L\]; 11. Patients with severe pulmonary insufficiency who cannot tolerate general anesthesia;

Get updates

Get notified about this study

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

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

aortic aneurysm Aortic Aneurysm, Thoracoabdominal

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asklepios Klinik Nord Heidberg

    RECRUITING

    Hamburg, Germany

More trials for these conditions

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