NCT06675617 EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
| NCT ID | NCT06675617 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Intressa Vascular SA |
| Condition | Type B Aortic Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2024-10-30 |
| Primary Completion | 2027-06 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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