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New stent graft aims to prevent deadly aneurysm rupture
NCT ID NCT04383145
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a special stent graft system designed to treat thoracoabdominal aortic aneurysms, a life-threatening condition where the main artery bulges. The device is placed inside the artery to support the weakened wall and prevent rupture. Researchers are following 150 patients to see how well it works and how safe it is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- E-nside TAAA multibranch stent graft system
- What this could lead to
- If successful, this device could offer a less invasive way to treat complex aortic aneurysms and reduce the risk of rupture and death.
- What could go wrong
- This is a post-market study, so the device is already approved. However, it is still being evaluated in a moderate-sized group, and risks like rupture or major adverse events remain possible.
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
-
About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2020
- Expected to finish
-
Feb 2030
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.
Who is studied
Male and female patients with degenerative, atherosclerotic thoracoabdominal aortic aneurysm who are scheduled for implantation of an E-nside TAAA Multibranch Stent Graft at their physician's discretion and who are eligible in accordance with the inclusion / exclusion criteria.
- Ages
-
18 to 85 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: * Patient is between 18 and 85 years old * Patient has a degenerative, atherosclerotic thoracoabdominal aortic aneurysm * Patient has adequate iliac/femoral access compatible with an 8.5 mm OD delivery system * Patient's aorta has no distinct angulation in the thoracovisceral segment of the aorta ranging from 40 mm proximal to the celiac trunk to 20 mm distal to the lowest renal artery * All target branch vessels are suitable for antegrade cannulation * Diameter of the landing zone in each branch vessel to be treated is ≥ 5 mm * Length of landing zone in each branch vessel to be treated is ≥ 15 mm (preferably ≥ 20 mm) * Patient must be available for the appropriate follow-up times for the duration of the study * Patient has signed the informed consent before implantation of the E-nside Stent Graft Exclusion Criteria: * Patient has allergies to materials necessary for endovascular repair (e.g. contrast media, anticoagulants or heparin, nitinol, polyester, gold, platinum-iridium) * Patient has systemic infection or suspected systemic infection * Patient has an infectious aneurysm * Patient has an inflammatory aneurysm * Patient has a ruptured aneurysm * Patient has a traumatic aneurysm * Patient has a symptomatic aneurysm * Patient has an aortic dissection * Patient has a congenital degenerative collagen disease or connective tissue disorder * Diameter of ostium of branch vessel to be treated \< 4 mm * Patient has thrombocytopenia (platelet count \< 150000/µl) * Patient has an eGFR \< 30 ml/min/1.73m2 before the enrolment * Patient has untreated hyperthyroidism * Patient has a malignancy (progressive, stable or partial remission) with less than one-year projected survival * Patient had a myocardial infarction or cerebrovascular accident \< 3 months ago * Patient is planned to be treated with a chimney in the left subclavian artery * Patient has had a previous surgical repair of descending thoracic aorta * Patient will be treated or had been treated with a Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) or Anaconda (Vascutek) stent graft * Patient is enrolled or plans to be enrolled in another clinical study * Patient is pregnant or breastfeeding or planning to become pregnant during the course of the study. * Patient has a life expectancy of less than 3 years
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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.
Contacts and locations
Locations
-
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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