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Clinical Trials in Germany / NCT06675617
Recruiting Not applicable

EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn

NCT06675617 · tracked via the Priya Life Science Germany tracker
Sponsor
Intressa Vascular SA
Phase
Not applicable
Started
2024-10-30
Last updated
2026-09-16

Condition(s) studied

Type B Aortic Dissection

Investigational drug(s) / intervention(s)

Allay Aortic Stent

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)

Trial sites (21)

FacilityCityRegionStatus
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.

View NCT06675617 on ClinicalTrials.gov ↗ ← All trials in Germany