LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

NCT07259018 | Not Yet Recruiting DMC

• 1 other identifier: PRT-0000357
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

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: 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 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)

LuSeed Aneurysm Embolization System

EXPERIMENTAL

Device: LuSeed Aneurysm Embolization System

Interventions

LuSeed Aneurysm Embolization System DEVICE

LuSeed Aneurysm Embolization System EFS Canada

LuSeed Aneurysm Embolization System

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 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.
• Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements
• Patient able to give their informed consent can be included in this study.

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
• Intracranial aneurysm minimum height 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 (1)

St. Michael's Hospital - Unity Health Toronto

Toronto, Ontario, M5C 1R6, Canada

Location

Related Publications (5)

• 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.

  PMID: 16139655 BACKGROUND

• 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; 2026 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

Central Study Contacts

Nitzan Hirsh

CONTACT

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

Gali Vino

CONTACT

+972-525527565; galiv@luseed-vascular.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

CA (1)