NCT06761365

LUMENS-1 EU EFS CIP

A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED INTRACRANIAL ANEURYSMS

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: LuSeed Vascular LTD. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

LuSeed Vascular is sponsoring a prospective, multi-center single arm clinical trial enrollment initiated on October 2024 to assess early safety and feasibility of the LuSeed Aneurysm Embolization System for the treatment of unruptured intracranial aneurysms (IA).

Conditions

• Aneurysm Cerebral
• Bifurcation
• Unruptured Intracranial Aneurysm
• Saccular Aneurysm
• Brain Aneurysm

Interventions

Type	Name	Description
DEVICE	LuSeed Aneurysm Embolization System	a permanent intrasaccular implant used for treatment of unruptured intracranial saccular aneurysms (IA) in adult patients according to international guidelines who are indicated for non-emergent endovascular embolization of saccular IAs at the time of presentation.

Timeline

• Start date: 2024-10-07
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2025-01-07
• Last updated: 2025-11-26

Locations

6 sites across 4 countries: Bulgaria, Germany, Israel, Poland