Clinical trial Recruiting at 16 sites Interventional Ages 18 and up

Treatment for Type B Aortic Dissection using Allay Aortic Stent

Official title: A Clinical Study to Evaluate the Effectiveness and Safety of the Allay® Aortic Stent as Adjunctive Endovascular Treatment of Type B Aortic Dissection in Patients Eligible for Thoracic Endovascular Repair With Stent Grafts

Run by Intressa Vascular SA · NCT06675617 · Data updated 2026-11-12

This study is testing if adding the Allay® Aortic Stent to standard treatment can help people with Type B aortic dissection avoid serious complications and aortic growth.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment72 (estimated)
SponsorIntressa Vascular SA
Industry-sponsored
Locations21 sites (Salzburg and 20 other locations)
StatusRecruiting
StartedOctober 30, 2024
Main results expectedJune 2027
Study endsJune 2031
Registry record updatedSeptember 16, 2026
Trial IDNCT06675617 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with Type B aortic dissection extending to the celiac trunk who are eligible for thoracic endovascular treatment.

Probably not a fit

Patients with aortic rupture or those under 18 years old will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of the Allay® Aortic Stent as an adjunctive treatment for Type B aortic dissection in patients eligible for thoracic endovascular aortic repair (TEVAR). The study involves the placement of a CE-marked Thoracic Stent Graft followed by the implantation of the Allay® Aortic Stent to reduce the risk of aortic growth and complications. It aims to demonstrate a low rate of aortic growth requiring secondary interventions or rupture within 12 months, while also assessing major adverse events within 30 days post-implantation.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of complications associated with Type B aortic dissection.

How similar studies have gone: Other studies have shown success with similar endovascular approaches, suggesting potential for positive outcomes in this trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Ziekenhuis Oost-Limburg
    Genk, Belgium
    Recruiting
  • UZ Leuven
    Leuven, Belgium
    Recruiting
  • CHU Liège
    Liège, Belgium
    Recruiting
  • Acibadem City Clinic University Hospital and Cardiovascular Center
    Sofia, Bulgaria
    Recruiting
  • Uniklinik Düsseldorf
    Düsseldorf, Germany
    Recruiting
  • Universitätsklinikum Schleswig-Holstein
    Kiel, Germany
    Recruiting
Show 15 more locations
  • Universitätsklinikum Leipzig AöR
    Leipzig, Germany
    Recruiting
  • TUM Klinikum rechts der Isar
    München, Germany
    Recruiting
  • University Hospital of Münster
    Münster, Germany
    Recruiting
  • Szpital Uniwersytecki nr 1 im. A. Jurasza w Bydgoszczy
    Bydgoszcz, Poland
    Recruiting
  • Uniwersytecki Szpital Kliniczny w Opolu
    Opole, Poland
    Recruiting
  • Uniwersytecki Szpital Kliniczny w Poznaniu
    Poznan, Poland
    Recruiting
  • Kliniczny Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie
    Rzeszów, Poland
    Recruiting
  • Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
    Warsaw, Poland
    Recruiting
  • Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze
    Zielona Góra, Poland
    Recruiting
  • University Clinical Centre of Serbia
    Belgrade, Serbia
    Recruiting
  • Paracelsus Medical University Salzburg
    Salzburg, Austria
    Not yet recruiting
  • CHU de Bordeaux (Hôpital Pellegrin)
    Bordeaux, France
    Not yet recruiting
  • Hopital Européen Georges Pompidou AP-HP
    Paris, France
    Not yet recruiting
  • Universitätsmedizin Frankfurt
    Frankfurt, Germany
    Not yet recruiting
  • Republican Research Centre of Emergency Medicine
    Tashkent, Uzbekistan
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.