Allay Aortic Stent: Endovascular treatment of an aortic dissection
Study summary
This clinical trial is a prospective, multicenter, open label study designed to evaluate the effectiveness and the safety of the Allay® Aortic Stent as adjunctive endovascular treatment of Type B aortic dissection in patients eligible for thoracic endovascular aortic repair with stent grafts.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Freedom from aortic growth requiring secondary reintervention, including open conversion, or aortic rupture in the region treated by the Allay® Aortic Stent at 12 months — 12 months An aortic growth requiring reintervention in the region treated with the Allay® Aortic Stent is defined as an increase in maximum aortic transverse diameter \>10mm at 12 months relative to the first post-operative CT scan done at discharge and not later than 30 days.
Trial sites (21)
Facility
City
Region
Status
Paracelsus Medical University Salzburg
Salzburg
Austria
Not Yet Recruiting
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
CHU de Bordeaux (Hôpital Pellegrin)
Bordeaux
France
Not Yet Recruiting
Hopital Européen Georges Pompidou AP-HP
Paris
France
Not Yet Recruiting
Uniklinik Düsseldorf
Düsseldorf
Germany
Recruiting
Universitätsmedizin Frankfurt
Frankfurt
Germany
Not Yet Recruiting
Universitätsklinikum Schleswig-Holstein
Kiel
Germany
Recruiting
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
Republican Research Centre of Emergency Medicine
Tashkent
Uzbekistan
Active Not Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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