Clinical trial NCT06761365: LUMENS-1 EU EFS CIP
Official title: A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY of the LUSEED ANEURYSM EMBOLIZATION SYSTEM in INDIVIDUALS with UPRUPTURED INTRACRANIAL ANEURYSMS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aneurysm Cerebral
Bifurcation
Unruptured Intracranial Aneurysm
Saccular Aneurysm
Brain Aneurysm
Keywords: Bifurcation
Embolization
Flow Diverter
Intrasaccular Device
Cerebral Aneurysm
Unruptured
Lead sponsor: LuSeed Vascular LTD.
Sponsor class: INDUSTRY
First posted: 2025-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 30 Days Post Study Procedure
measure: Primary Feasibility Endpoint
timeFrame: Day 0
Secondary outcomes:
measure: Secondary Safety Endpoints
timeFrame: 12 months
measure: Secondary Safety Endpoints
timeFrame: 12 months
measure: Secondary Safety Endpoints
timeFrame: 12 months
measure: Secondary Effectiveness Endpoints
timeFrame: 6-months and 12-months after treatment
measure: Secondary Effectiveness Endpoints
timeFrame: Day-30, 6-months, and 12-months
Other outcomes:
Locations:
city: Sophia
country: Bulgaria
facility: University Hospital :St. Ivan Rilski"
Study officials:
name: Vitor Pereira, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.
citation: 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/
citation: 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.