LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

A Single-arm, Open Label, Single-center Early Feasibility Study of the LuSeed Aneurysm Embolization System in Individuals With Unruptured 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 single-arm, open-label, single-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 10 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled in a Canadian site.

Study Overview

• Status: Not yet recruiting
• Conditions: Unruptured Intracranial Aneurysm; Saccular Aneurysm; Brain Aneurysm; Aneurysm Cerebral; Bifurcation
• Intervention / Treatment: Device: LuSeed Aneurysm Embolization System

Detailed Description

LuSeed Vascular will sponsor the study and the study will assess early safety and feasibility of the LuSeed Aneurysm Embolization System for the treatment of unruptured intracranial aneurysms (IA).

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nitzan Hirsh; Phone Number: +972-545333200; Email: Nitzan.h@luseed-vascular.com
• Study Contact Backup: Name: Gali Vino; Phone Number: +972-525527565; Email: galiv@luseed-vascular.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 1R6
      • St. Michael's Hospital - Unity Health Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
2. Age 18-80 years at screening
3. Patients who are suitable for non-emergency endovascular embolization of saccular IAs

4. The IA must have had the following characteristics:

   • IA located in bifurcation 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]
   • IA Height: min 4.0 [mm]- device short configuration, min 5.0 [mm]-device long configuration • The AI must meet the definition of a "wide-neck" aneurysm.
5. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements
6. Patient able to give their informed consent can be included in this study.

Exclusion Criteria:

1. Ruptured intracranial aneurysm
2. Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab
3. Contraindication for arterial access
4. Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm
5. Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm
6. Intracranial aneurysm minimum height less than 4.0 mm
7. Target Intracranial aneurysm contains other devices/implants (e.g., coils)
8. Stenosis of the target IA's parent vessel >50%
9. Known allergy to platinum, nickel, or titanium
10. Known allergy to contrast agents
11. Absolute contraindication to anticoagulation or antiplatelet therapy
12. Anticoagulation medications such as warfarin that cannot be discontinued
13. Pregnant, breastfeeding or planning pregnancy within next 12 months
14. Acute or chronic renal failure (stage III or IV by VARC-3 criteria)
15. Cerebral embolism, stroke, or TIA in past 6 months
16. Myocardial infarction in the past 6 months
17. Any other medical issue within the brain that would preclude device implantation (such as brain surgery, radiation in the target area of intervention from an external beam source, acute traumatic craniocerebral injury, etc.)
18. Patient had any circulatory, neurovascular, cardiovascular, or neurologic conditions that resulted in unstable neurological symptoms at screening.
19. Patient had physical, neurologic or psychiatric conditions which precluded his/her ability to comply with all aspects of the screening, evaluation, treatment, and the postprocedure follow-up schedule.
20. Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures (e.g., extreme frailty, liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.)
21. Patient had a life expectancy of less than 12 months.
22. Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LuSeed Aneurysm Embolization System	Device: LuSeed Aneurysm Embolization System; LuSeed Aneurysm Embolization System EFS Canada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: a. Success in accessing target intracranial aneurysm (IA) with the LuSeed Aneurysm Embolization System b. Successful visual confirmation of the LuSeed Aneurysm Embolization System Successful deployment and detachment of the LuSeed Aneurysm Embolization System	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoints	Percentage of participants with death of non-accidental cause or device related death, or major disabling stroke at 6 months and 12 months.	12 months
Secondary Safety Endpoints	Percentage of participants with serious adverse events within the first 30 days after treatment, 6 months and 12 months.	12 months
Secondary Effectiveness Endpoints	Proportion of subjects with Complete Aneurysm Occlusion immediate post procedure.	6-months and 12-months after treatment
Secondary Safety Endpoints	Percentage of participants presenting each component of the safety composite within first 30 days after treatment, 6 months and 12 months	12 months
Secondary Effectiveness Endpoints	Change in mRS between baseline.	Day-30, 6-months and 12-months

Collaborators and Investigators

• Sponsor: LuSeed Vascular LTD.

Publications and helpful links

General Publications

• Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17. doi: 10.1016/S0140-6736(05)67214-5.
• Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.
• 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.
• 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.
• 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/

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 2, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: PRT-0000357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No