EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
ConditionType B Aortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntressa Vascular SA
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Allay Aortic Stent
Treatment groups
72 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov