LUMENS-1 EU EFS CIP

NCT06761365 | Recruiting DMC

• 1 other identifier: PRT-0000264
• Study Type: interventional
• Target: 30
• Locations: 4 countries
• Sites: 6

Brief 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.

Conditions

Aneurysm Cerebral; Bifurcation; Unruptured Intracranial Aneurysm; Saccular Aneurysm; Brain Aneurysm

Keywords

Bifurcation; Embolization; Flow Diverter; Intrasaccular Device; Cerebral Aneurysm; Unruptured

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Death of any non-accidental cause, Procedure or Device Related Death or Any Major Disabling Stroke \*An independent Medical Monitor (IMM) will adjudicate all data used for safety endpoint analyses

  30 Days Post Study Procedure

• Primary Feasibility Endpoint

  Technical Success as defined by: 1. Success in accessing target intracranial aneurysm (IA) with the LuSeed Aneurysm Embolization System 2. Successful visual confirmation of the LuSeed Aneurysm Embolization System Successful deployment and detachment of the LuSeed Aneurysm Embolization System

  Day 0

Secondary Outcomes (5)

• Secondary Safety Endpoints

  12 months

• Secondary Safety Endpoints

  12 months

• Secondary Safety Endpoints

  12 months

• Secondary Effectiveness Endpoints

  6-months and 12-months after treatment

• Secondary Effectiveness Endpoints

  Day-30, 6-months, and 12-months

Study Arms (1)

The study population includes adult patients with an unruptured intracranial saccular aneurysms (IA)

EXPERIMENTAL

All eligible patients who underwent an attempt with the LuSeed Aneurysm Embolization System.

Device: LuSeed Aneurysm Embolization System

Interventions

LuSeed Aneurysm Embolization System DEVICE

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.

The study population includes adult patients with an unruptured intracranial saccular aneurysms (IA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\[mm\]

You may not qualify if:

• Ruptured intracranial aneurysm
• Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab
• Contraindication for arterial access
• Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm
• Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm
• Intracarnial aneurysm minimum hight less than 4.0 mm
• Target Intracranial aneurysm contains other devices/implants (e.g., coils)
• Stenosis of the target IA's parent vessel \>50%
• Known allergy to platinum, nickel, or titanium
• Known allergy to contrast agents
• Absolute contraindication to anticoagulation or antiplatelet therapy
• Anticoagulation medications such as warfarin that cannot be discontinued
• Pregnant, breastfeeding or planning pregnancy within next 12 months
• Acute or chronic renal failure (stage III or IV by VARC-3 criteria)
• Cerebral embolism, stroke, or TIA in past 6 months

Sponsors & Collaborators

• LuSeed Vascular LTD.: lead

Study Sites (6)

University Hospital St. Ivan Rilski

Sofia, Bulgaria

RECRUITING

The University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

UCK Katowice

Katowice, Poland

RECRUITING

Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz

Lodz, Poland

RECRUITING

Jan Mikulicz-Radecki University Clinical Hospital in Wrocław

Wroclaw, Poland

NOT YET RECRUITING

Related Publications (4)

• Brinjikji W, Cloft HJ, Kallmes DF. Difficult aneurysms for endovascular treatment: overwide or undertall? AJNR Am J Neuroradiol. 2009 Sep;30(8):1513-7. doi: 10.3174/ajnr.A1633. Epub 2009 May 20.

  PMID: 19461057 BACKGROUND

• Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.

  PMID: 18523626 BACKGROUND

• Faluk M, Das JM, De Jesus O. Saccular Aneurysm. 2024 Mar 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557867/

  PMID: 32491790 BACKGROUND

• Bhaskaran G. INTERNATIONAL JOURNAL OF CURRENT MEDICAL AND PHARMACEUTICAL RESEARCH BRAIN (CEREBRAL) ANEURYSM. November 2018;4:3844-8. https://doi.org/10.24327/23956429.ijcmpr20180569.

  BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm; Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vitor Pereira, MD MSc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitzan Hirsh

CONTACT

972-545333200; Nitzan.h@luseed-vascular.com

Gali Vino

CONTACT

972525527565; galiv@luseed-vascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2024
• First Posted: January 7, 2025
• Study Start: October 7, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Following final study analysis.
• Access Criteria: Investigational sites.

Locations

BU (1); IL (1); PL (3); DE (1)