The Aortoseal Endostapling System is intended to provide enhanced fixation between an endovascular graft and the native aorta and to provide enhanced apposition of the endovascular graft to the native aorta.
It is indicated in patients undergoing, or having undergone, treatment of an abdominal aortic aneurysm (AAA) with an endovascular graft to provide enhanced fixation and apposition to the aorta. The device may be implanted at the time of the initial endovascular graft procedure to maintain, or during a secondary procedure to restore, adequate aneurysm.
Sponsor
Endoron Medical Ltd., Israel
Study objectives
Safety & Feasibility Evaluation of the Aortoseal™ for seal and fixation of abdominal aortic aneurysms (AAA) endovascular grafts to the aortic wall.
Primary endpoints
The study is an Early Feasibility Study . There are no pre-defined primary endpoints. The data generated from this study will inform the future pivotal study
Endpoints related to the endovascular graft and Aortoseal Endostapling System collected throughout the study are:
- All types of endoleaks, subcategorized by type, assessed by the core lab
- Aortoseal device and endovascular graft migration, assessed by the core lab
- Kink of the endovascular graft at the margin of the Aortoseal Implant
- Aneurysm size change, assessed by the core lab
Countries
Israel, EU and Georgia
Number of investigational sites
17
