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Can an extra stent stop a torn aorta from growing?

NCT ID NCT06675617

Disease control Sponsor: Intressa Vascular SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether adding the Allay Aortic Stent to the usual stent-graft procedure can better treat type B aortic dissection, a tear in the aorta's wall. About 72 people who qualify for standard endovascular repair will receive the Allay stent during their procedure. Researchers will check at 12 months whether the treated area avoids dangerous growth or rupture that would need another intervention.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Allay Aortic Stent, a device placed inside the aorta during endovascular repair
What this could lead to
If it works, adding the Allay Aortic Stent to standard stent grafting could reduce the need for repeat procedures and lower the risk of aortic rupture in people with type B aortic dissection.
What could go wrong
This is a mid-sized trial with 72 participants, and the device is still being tested. It may not prove better than standard care, and device implantation carries risks such as vessel damage or stent movement.

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

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

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Jun 2031

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.

Ages

18 years and older

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: * Have a type B aortic dissection extending to the celiac trunk or beyond * Are eligible for thoracic endovascular treatment with stent grafts as per local guidelines, and physician's decision * Have been elected for treatment with commercially available stent graft as per their IFU within 90 days of dissection symptoms onset Exclusion Criteria: * General Exclusion Criteria: * Age \< 18 years * Pregnant, breast-feeding or planning on becoming pregnant during the entire duration of the study * Unable to provide written informed consent * Unable or unwilling to comply with the requirements of the study protocol * Taking part already in an investigational device or drug study that could interfere with the outcomes being studied * Active drug addiction or known history of drug abuse within one year of treatment * Medical Exclusion Criteria: * Aortic rupture (free or contained including haemothorax, increasing periaortic hematoma, or mediastinal hematoma) * Aortic fistula * Suspicion of bowel necrosis or irreversible visceral ischemia * Stage 5 chronic kidney disease * Life expectancy of less than 2 years due to any other medical condition than the dissection to be treated * Active malignancy * Known sensitivities or allergies to the device materials (including cobalt, chromium, nickel) * Known sensitivities or allergies to contrast materials that cannot be pre-medicated * Mycotic aortic aneurysm or active systemic infection that may place the patient at increased risk of endovascular infection * American Society of Anaesthesiologists (ASA) class V (moribund patient not expected to live 24 hours with or without operation) * Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's, Loeys-Dietz or Ehlers-Danlos syndrome) * Uncorrectable coagulopathy, bleeding diathesis or refusal of blood transfusion * Any major cardiovascular or cerebrovascular ischemic event, including myocardial infarction or stroke, or treatment of such event, within 90 days prior to enrolment * Any aortic-related interventional or surgical procedure within 30 days prior to enrolment * Any planned aortic-related interventional or surgical procedure within 30 days after the study procedure * Anatomical Exclusion Criteria: * Aneurysmal dilatation of the false lumen defined as maximum transaortic diameter \>55 mm in women or \>60 mm in men in the thoraco-abdominal segment or \>50 mm in women or \>55 mm in men in the abdominal segment, measured inner-wall to inner-wall; * Inadequate proximal landing zone for the stent graft, such zone being \<20 mm long * Inadequate proximal landing zone geometry for the Allay® Aortic Stent (e.g. aortic kink) * Planned implantation of a stent graft with a distal diameter \>38 mm or \<20 mm * Aorta or iliac anatomy not allowing the advancement of the delivery system * Subject in whom the thoracic stent graft is either 1) not implanted in its intended position and/or 2) leads to any serious device complication, and/or who has 3) persistent static obstruction of the visceral or both renal arteries, prior to Allay® Aortic Stent implantation, will not be implanted with the Allay® Aortic Stent and will be withdrawn from the study

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type B aortic dissection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Acibadem City Clinic University Hospital and Cardiovascular Center

    RECRUITING

    Sofia, 1407, Bulgaria

  • CHU Liège

    RECRUITING

    Liège, 4000, Belgium

  • CHU de Bordeaux (Hôpital Pellegrin)

    NOT_YET_RECRUITING

    Bordeaux, France

  • Hopital Européen Georges Pompidou AP-HP

    NOT_YET_RECRUITING

    Paris, 75015, France

  • Kliniczny Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie

    RECRUITING

    Rzeszów, 35-301, Poland

  • Paracelsus Medical University Salzburg

    NOT_YET_RECRUITING

    Salzburg, 5020, Austria

  • Republican Research Centre of Emergency Medicine

    ACTIVE_NOT_RECRUITING

    Tashkent, 100107, Uzbekistan

  • Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze

    RECRUITING

    Zielona Góra, 65-046, Poland

  • Szpital Uniwersytecki nr 1 im. A. Jurasza w Bydgoszczy

    RECRUITING

    Bydgoszcz, 85-094, Poland

  • TUM Klinikum rechts der Isar

    RECRUITING

    München, 81675, Germany

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Uniklinik Düsseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • University Clinical Centre of Serbia

    RECRUITING

    Belgrade, 11000, Serbia

  • University Hospital of Münster

    RECRUITING

    Münster, 48149, Germany

  • Universitätsklinikum Leipzig AöR

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Schleswig-Holstein

    RECRUITING

    Kiel, 24105, Germany

  • Universitätsmedizin Frankfurt

    NOT_YET_RECRUITING

    Frankfurt, 60590, Germany

  • Uniwersytecki Szpital Kliniczny w Opolu

    RECRUITING

    Opole, 45-401, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, 61-848, Poland

  • Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy

    RECRUITING

    Warsaw, 04-141, Poland

  • Ziekenhuis Oost-Limburg

    RECRUITING

    Genk, 3600, Belgium

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