Aneurysm CerebralNCT06761365
LUMENS-1 EU EFS CIP
A study testing LuSeed Aneurysm Embolization System in people with Aneurysm Cerebral and Bifurcation, run by LuSeed Vascular LTD. at 6 sites in 4 countries.
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
- Conditions the study is for
- Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm
- 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
- 30 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 7 Oct 2024to Jun 2027
- 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 the anterior or posterior circulation
- IA dimensions appropriate for treatment with
Show all 32Show fewer
- 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 4. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements Exclusion Criteria: 5. Patient able to give their informed consent can be included in this study. Exclusion Criteria
- 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
- 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.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Poland3 sites, 3 recruiting
- Recruiting
UCK Katowice
Katowice
tompekala@gmail.com
Tomasz Pekala
- Recruiting
Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
Lodz
dariusz.jaskolski@umed.lodz.pl
Dariusz Jaskolski
- Not yet recruiting
Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
Wroclaw
mis.neurochirurg@gmail.com
Maciej Mis
Bulgaria1 site, 1 recruiting
- Recruiting
University Hospital St. Ivan Rilski
Sofia
Stanislav Sirakov, Prof., ssirakov@bsunivers.com
Stanislav Sirakov, Prof.
Germany1 site, 1 recruiting
- Recruiting
The University Medical Center Hamburg-Eppendorf
Hamburg
f.flottmann@uke.de
Fabian Flottmann
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel Litwinsky
David.Orion@sheba.health.gov.il
David Orion
About this study
Official title: A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED 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 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.
Read the 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
- Being tested
- LuSeed Aneurysm Embolization System
- Keywords
- Bifurcation, Embolization, Flow Diverter, Intrasaccular Device, Cerebral Aneurysm, Unruptured
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LuSeed Aneurysm Embolization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Primary Feasibility Endpoint
Technical Success as defined by:
- Success in accessing target intracranial aneurysm (IA) with the LuSeed Aneurysm Embolization System
- 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)
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
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
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
Secondary Effectiveness Endpoints
Proportion of subjects with Complete Aneurysm Occlusion immediate post procedure.
Measured: 6-months and 12-months after treatment
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.
- First posted7 Jan 2025
- Study start7 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Aneurysm CerebralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LuSeed Vascular LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vitor Pereira, MD MSc, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761365
- Sponsor's protocol ID
- PRT-0000264
- Status last verified
- Nov 2025
- First submitted
- 22 Dec 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: demographics, health outcomes, laboratory results, responses to treatment.
Publications
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 19461057Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.
PubMed 18523626Faluk 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 32491790Bhaskaran G. INTERNATIONAL JOURNAL OF CURRENT MEDICAL AND PHARMACEUTICAL RESEARCH BRAIN (CEREBRAL) ANEURYSM. November 2018;4:3844-8. https://doi.org/10.24327/23956429.ijcmpr20180569.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED INTRACRANIAL ANEURYSMS
- ClinicalTrials.gov ID
- NCT06761365
- Acronym / sponsor ID
- PRT-0000264
- Conditions
- Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm, Brain Aneurysm
- Keywords
- Bifurcation, Embolization, Flow Diverter, Intrasaccular Device, Cerebral Aneurysm, Unruptured
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LuSeed Vascular LTD.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population includes adult patients with an unruptured intracranial saccular aneurysms (IA) | Experimental | Device: LuSeed Aneurysm Embolization SystemAll eligible patients who underwent an attempt with the LuSeed Aneurysm Embolization System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
- 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]
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LuSeed Aneurysm Embolization Systema 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. | Device | The study population includes adult patients with an unruptured intracranial saccular aneurysms (IA) |
Primary outcome
Primary Safety Endpoint
Time frame: 30 Days Post Study Procedure
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
Primary Feasibility Endpoint
Time frame: Day 0
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
5 secondary outcomes
Secondary Safety Endpoints
Time frame: 12 months
Secondary Safety Endpoints
Time frame: 12 months
Secondary Safety Endpoints
Time frame: 12 months
Secondary Effectiveness Endpoints
Time frame: 6-months and 12-months after treatment
Secondary Effectiveness Endpoints
Time frame: Day-30, 6-months, and 12-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 19461057Brinjikji 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.
- Background: PubMed 18523626Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.
- Background: PubMed 32491790Faluk 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/
- BackgroundBhaskaran G. INTERNATIONAL JOURNAL OF CURRENT MEDICAL AND PHARMACEUTICAL RESEARCH BRAIN (CEREBRAL) ANEURYSM. November 2018;4:3844-8. https://doi.org/10.24327/23956429.ijcmpr20180569.
- Individual participant dataSharing planned: Yes. demographics, health outcomes, laboratory results, responses to treatment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vitor Pereira, MD MSc principal investigator
6 sites in 4 countries: see every site and its status.
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 6 sites in 4 countries.
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 32 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, Bulgaria, Germany, Israel. 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 NCT06761365, which also lists 4 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 26 Nov 2025.