EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn

Recruiting now · Not applicable

Conditions studied: Type B Aortic Dissection

In brief

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.

Key facts

Study ID

NCT06675617

Run by

Intressa Vascular SA

People needed

72

Starts

2024-10-30

Expected to finish

2031-06-01

Last updated by the study team

2025-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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;

Where it is running

• Republican Research Centre of Emergency Medicine — Tashkent, Uzbekistan (enrolling)
• CHU Liège — Liège, Belgium (enrolling)
• Universitätsklinikum Schleswig-Holstein — Kiel, Germany (enrolling)
• Universitätsklinikum Leipzig AöR — Leipzig, Germany (enrolling)
• Hopital Européen Georges Pompidou AP-HP — Paris, France
• University Clinical Centre of Serbia — Belgrade, Serbia
• Ziekenhuis Oost-Limburg — Genk, Belgium
• UZ Leuven — Leuven, Belgium
• University Hospital of Münster — Münster, Germany
• Acibadem City Clinic University Hospital and Cardiovascular Center — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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