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New stent graft under scrutiny for aortic repair

NCT ID NCT05639569

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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.

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Conditions

The condition(s) this trial relates to.

Dissection, Thoracic Aorta thoracic aortic aneurysm

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

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