A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY of the LUSEED ANEURYSM EMBOLIZATION SYSTEM in INDIVIDUALS with UPRUPTURED INTRACRANIAL ANEURYSMS
The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA). This is a prospective, single-arm, open-label, multi-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 30 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled across a maximum of 10 medical centers in the EU.
• Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
‣ Age 18-80 years at screening
⁃ Patients who are suitable for non-emergency endovascular embolization of saccular IAs
⁃ The IA must have had the following characteristics:
• IA located in the anterior or posterior circulation
• IA dimensions appropriate for treatment with
∙ LuSeed-Vascular Embolization Device per implant size selection guidelines as outlined in the Instructions for Use (IFU) and as follows:
• IA Width: 2.5-5.5\[mm\]
• IA Neck: 2.0-5.0\[mm\]