LUMENS-1 EU EFS CIP

November 21, 2025 updated by: LuSeed Vascular LTD.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bulgaria
      • Sofia, Bulgaria
        • Recruiting
        • University Hospital St. Ivan Rilski
        • Contact:
        • Principal Investigator:
          • Stanislav Sirakov, Prof.
  • Germany
      • Hamburg, Germany
        • Recruiting
        • The University Medical Center Hamburg-Eppendorf
        • Contact:
        • Principal Investigator:
          • Fabian Flottmann
        • Sub-Investigator:
          • Jens Fiehler
  • Israel
  • Poland
      • Katowice, Poland
        • Recruiting
        • UCK Katowice
        • Contact:
        • Principal Investigator:
          • Tomasz Pekala
      • Lodz, Poland
        • Recruiting
        • Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
        • Contact:
        • Principal Investigator:
          • Dariusz Jaskolski
      • Wroclaw, Poland
        • Not yet recruiting
        • Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
        • Contact:
        • Principal Investigator:
          • Maciej Mis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.

    1. Age 18-80 years at screening
    2. Patients who are suitable for non-emergency endovascular embolization of saccular IAs
    3. 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]

  • 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

    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. Intracarnial aneurysm minimum hight 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The study population includes adult patients with an unruptured intracranial saccular aneurysms (IA)
All eligible patients who underwent an attempt with the LuSeed Aneurysm Embolization System.
Device: LuSeed Aneurysm Embolization System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 Days Post Study Procedure
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
Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LuSeed Vascular LTD.

Investigators

  • Principal Investigator: Vitor Pereira, MD MSc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRT-0000264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

demographics, health outcomes, laboratory results, responses to treatment.

IPD Sharing Time Frame

Following final study analysis.

IPD Sharing Access Criteria

Investigational sites.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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