New stent graft aims to fix dangerous aortic aneurysms without open surgery
NCT ID NCT05954793
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a device called the E-nside stent graft system in 30 people with thoracoabdominal aortic aneurysms (a bulge in the main artery that runs through the chest and belly). The goal is to see if the device is safe and works well when placed inside the artery to repair the aneurysm. Participants are being followed to track survival, aneurysm rupture, and any major complications.
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 stent graft could offer a safer, less invasive way to treat complex aortic aneurysms, potentially reducing the need for open surgery.
- What could go wrong
- This is a small, post-market study with only 30 participants, so results may not apply to all patients. Risks include rupture, major adverse events, or need for additional procedures.
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
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Feb 2026
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.
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 criteria listed below.
- Ages
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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 intervention * Patient has untreated hyperthyroidism * Patient has a malignancy (progressive, stable or partial remission) * 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
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Alfred Health
Melbourne, 3004, Australia
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Auckland City Hospital
Auckland, 1023, New Zealand
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Gold Coast University Hospital
Southport, 4215, Australia
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Prince of Songkla University - Songklanagarind Hospital
Songkhla, 90110, Thailand
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Royal North Shore Hospital
Saint Leonards, 2065, Australia
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Sir Charles Gairdner Hospital
Perth, 6009, Australia
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Siriraj Hospital
Bangkok, Thailand
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Waikato Hospital Hamilton
Hamilton, 3204, New Zealand
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 device aims to fix dangerous aortic bulge without major surgery
- New Stent-Graft procedure offers hope for High-Risk aortic patients