A Clinical Study to Evaluate the Effectiveness and Safety of the Allay® Aortic Stent as Adjunctive Endovascular Treatment of Type B Aortic Dissection in Patients Eligible for Thoracic Endovascular Repair With Stent Grafts
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Ziekenhuis Oost-Limburg
NOT_YET_RECRUITING
Genk
UZ Leuven
NOT_YET_RECRUITING
Leuven
CHU Liège
RECRUITING
Liège
Bulgaria
Acibadem City Clinic University Hospital and Cardiovascular Center
NOT_YET_RECRUITING
Sofia
France
Hopital Européen Georges Pompidou AP-HP
NOT_YET_RECRUITING
Paris
Germany
Universitätsklinikum Schleswig-Holstein
RECRUITING
Kiel
Universitätsklinikum Leipzig AöR
RECRUITING
Leipzig
University Hospital of Münster
NOT_YET_RECRUITING
Münster
Serbia
University Clinical Centre of Serbia
NOT_YET_RECRUITING
Belgrade
Uzbekistan
Republican Research Centre of Emergency Medicine
RECRUITING
Tashkent
Contact Information
Primary
Virginie Martin
virginie.martin@intressavascular.com
+3281 71 99 41
Time Frame
Start Date: 2024-10-30
Estimated Completion Date: 2031-06
Participants
Target number of participants: 72
Treatments
Experimental: Allay Aortic Stent
A covered thoracic stent graft is first deployed in supraceliac position as per standard of care then followed by the implantation of the Allay® Aortic Stent deployed from within the stent graft, extending below the celiac trunk to the end of the dissected aorta, typically the aortoiliac bifurcation.
Related Therapeutic Areas
Sponsors
Leads: Intressa Vascular SA