New stent device aims to fix dangerous aortic bulge without major surgery
NCT ID NCT06710938
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
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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
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About 11 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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: 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;
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Asklepios Klinik Nord Heidberg
RECRUITINGHamburg, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a tailored stent graft tame complex aortic aneurysms?
- A simple gas flush before aortic repair might prevent strokes
- New stent grafts aim to fix aortic aneurysms without major surgery
- Aortic Stent-Graft safety under the microscope: 600-Patient european registry launches
- New Stent-Graft procedure offers hope for High-Risk aortic patients
- Researchers check safety of stent grafts used in aortic aneurysm surgery