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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
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