AzTrials
AzTrials

Aneurysm CerebralNCT07259018

LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

A study testing LuSeed Aneurysm Embolization System in people with Aneurysm Cerebral and Bifurcation, run by LuSeed Vascular LTD. at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
LuSeed Aneurysm Embolization System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteCanada
Study dates
Dec 2025to May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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
  • Myocardial infarction in the past 6 months
  • 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.)
  • Patient had any circulatory, neurovascular, cardiovascular, or neurologic conditions that resulted in unstable neurological symptoms at screening.
  • 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.
  • 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.)
  • Patient had a life expectancy of less than 12 months.
  • Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nitzan Hirsh contact

+972-545333200

Nitzan.h@luseed-vascular.com

Gali Vino contact

+972-525527565

galiv@luseed-vascular.com

Canada1 site

  • St. Michael's Hospital - Unity Health Toronto

    Toronto, Ontario, M5C 1R6

Other trials in Canada

About this study

Official title: 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.

Read the 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).

Being tested
LuSeed Aneurysm Embolization System
Medical subject headings
Intracranial Aneurysm, Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LuSeed Aneurysm Embolization SystemDevice

    LuSeed Aneurysm Embolization System EFS Canada

Study groups in NCT07259018
Study groupRoleWhat they receive
LuSeed Aneurysm Embolization SystemExperimentalNot described
Receives: Device: LuSeed Aneurysm Embolization System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 Days Post Study Procedure

  2. 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

    Measured: Day 0

Secondary outcomes (5)

  1. 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.

    Measured: 12 months

  2. Secondary Safety Endpoints

    Percentage of participants presenting each component of the safety composite within first 30 days after treatment, 6 months and 12 months

    Measured: 12 months

  3. Secondary Safety Endpoints

    Percentage of participants with serious adverse events within the first 30 days after treatment, 6 months and 12 months.

    Measured: 12 months

  4. Secondary Effectiveness Endpoints

    Proportion of subjects with Complete Aneurysm Occlusion immediate post procedure.

    Measured: 6-months and 12-months after treatment

  5. Secondary Effectiveness Endpoints

    Change in mRS between baseline.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study startDec 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07259018
Sponsor's protocol ID
PRT-0000357
Status last verified
Dec 2025
First submitted
17 Nov 2025
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 16139655

  • 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.

    PubMed 19461057

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

    PubMed 18523626

  • 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/

    PubMed 32491790

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing LuSeed Aneurysm Embolization System in people with Aneurysm Cerebral and Bifurcation, run by LuSeed Vascular LTD. at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nitzan Hirsh (+972-545333200, Nitzan.h@luseed-vascular.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint (time frame: 30 Days Post Study Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07259018, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in