New stent graft under scrutiny for aortic repair
NCT ID NCT05639569
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is following 147 people who have a bulge (aneurysm) or tear (dissection) in the main artery of the chest. All participants received the Ankura stent graft, a fabric-covered metal tube placed inside the artery to support it. Researchers are tracking how well the device works and any complications over three years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ankura TAA Stent Graft System (a fabric-covered metal tube placed inside the aorta to reinforce the vessel wall)
- What this could lead to
- If successful, this study could confirm that the Ankura stent graft is a safe and effective option for treating thoracic aortic aneurysms and dissections, potentially expanding treatment access.
- What could go wrong
- This is an observational post-market study, not a randomized trial, so results may be less definitive. Risks include device-related complications like endoleaks, migration, or rupture, which are being monitored.
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
-
147 people
The number who actually took part.
- Started
-
May 2023
- Expected to finish
-
Dec 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
Patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD) and indicate for endovascular repair (TEVAR).
- Ages
-
18 to 85 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 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 has descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD), who needs endovascular repair (TEVAR). * Life expectancy \> 1 year. * Patient or legally authorized representative understands the nature of the clinical trial, agrees to its provisions, agrees to comply with the requirements of the study including a 3-year follow-up, and signed applicable Informed Consent Form. * Patient's characteristics consistent with Ankura™ Stent Graft System IFU and sizing guidelines, which indicate as following: 1. For descending thoracic aortic aneurysm (DTA) patient: * Adequate iliac/femoral access vessel that is compatible with the required delivery system. * Aortic inner diameter in the range of 18-42mm. * ≥15mm non-aneurysmal aorta proximal and distal to the lesion. * Morphology suitable for endovascular repair. 2. For type B aortic dissection (TBAD) patient: * Adequate iliac/femoral access vessel that is compatible with the required delivery system. * ≥15mm landing zone proximal to the primary entry tear; proximal extent of the landing zone must not be dissected. Diameter at proximal extent of proximal landing zone in the range of 16-44mm. * ≥15mm landing zone distal to the primary entry tear; distal extent of the landing zone must not be dissected. Diameter at distal extent of distal landing zone in the range of 16-44mm. * Morphology suitable for endovascular repair. Exclusion Criteria: * Patient with any contraindications mentioned in the Ankura™ Stent Graft System IFU: * Patients with acute systemic infection; * Patients who have had other devices implanted in the cardiovascular cavity, which will interfere with the placement of this device; * Patients with mesenteric blood flow mainly supplied by the inferior mesenteric artery; * Patients who have allergic reaction to the device; * Patients who are not suitable for endovascular repair in vascular morphology; * Patients who cannot tolerate contrast agents due to severe renal insufficiency; * Patients who are allergic to contrast agents; * Aneurysms neck with thrombus; * Non-aneurysmal aortic proximal neck length \<1.5cm; * Non-aneurysmal aortic distal anchorage zone \<1.5cm; * For aneurysms, Non-aneurysmal aortic diameter \<18mm or \>42mm. For Type B dissections, Non-aneurysmal aortic diameter \<16mm or \>44mm. * Patient with traumatic aortic injury; * Patient with uncorrectable coagulopathy; * Patient with hereditary connective tissue disease, including but not limited to Marfan Syndrome or Ehlers-Danlos Syndrome; * Patient with morbid obesity, weight greater than 350 Pounds (150kg), or who cannot undergo accurate fluoroscopy examination due to obesity; * Age\<18 Years or Age\> 85 Years; * Pregnant or plan to be pregnant or breast feeding; * Myocardial infarction or stroke within 3 months prior to the procedure; * American Society of Anesthesiologists Physical Status Classification (ASA) classification 5 or higher; * Patient with an unstable angina pectoris or hearth insufficiency New York Heart Association Functional Classification (NYHA) 3 or 4 * Participant in other drug or medical device clinical trials; * Patient with access vessel which are to tortuous, narrow or any kind of reasons that would lead to failure of introduction and advancing an introducer sheath; * Any condition (medical or anatomic) which makes the patient not suitable for endovascular repair according to the opinion of the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Aneurysm thoracic are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
A.O. Ordine Mauriziano di Torino
Turin, Italy
-
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
-
Ankara Etlik City Hospital
Ankara, Turkey (Türkiye)
-
Ankara University Hospital Heart Center
Ankara, Turkey (Türkiye)
-
Asklepios Klinik Nord Heidberg
Hamburg, Germany
-
Erzurum University Hospital
Erzurum, Turkey (Türkiye)
-
Eskişehir City Hospital
Eskişehir, Turkey (Türkiye)
-
Evaggelismos General Hospital
Athens, Greece
-
Federal State Budgetary Institution - V.A. Almazov National Medical Research Centre
Saint Petersburg, Russia
-
Gaziantep City Hospital
Gaziantep, Turkey (Türkiye)
-
General Hospital of Athens - Georgios Gennimatas
Athens, Greece
-
Izmir City Hospital
Izmir, Turkey (Türkiye)
-
Petrovsky National Research Centre of Surgery
Moscow, Russia
-
St. Franziskus Hospital Münster
Münster, Germany
-
University General Hospital - Attikon
Attiki, Greece
More trials for these conditions
Other studies related to the condition(s) this trial covers.