LUMENS-1 EU EFS CIP

Not Applicable

Recruiting

• Conditions: Aneurysm Cerebral; Bifurcation; Unruptured Intracranial Aneurysm; Saccular Aneurysm; Brain Aneurysm

• Registration Number: NCT06761365
• Lead Sponsor: LuSeed Vascular LTD.

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).

Study Timeline

• Study Start: 2024-10-07
• Status Verified: 2024-12
• Study First Submitted: 2024-12-22
• Study First Submitted QC: 2024-12-31
• Last Update Submitted: 2024-12-31
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

6. Ruptured intracranial aneurysm

7. Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab

8. Contraindication for arterial access

9. Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm

10. Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm

11. Intracarnial aneurysm minimum hight less than 4.0 mm

12. Target Intracranial aneurysm contains other devices/implants (e.g., coils)

13. Stenosis of the target IA's parent vessel >50%

14. Known allergy to platinum, nickel, or titanium

15. Known allergy to contrast agents

16. Absolute contraindication to anticoagulation or antiplatelet therapy

17. Anticoagulation medications such as warfarin that cannot be discontinued

18. Pregnant, breastfeeding or planning pregnancy within next 12 months

19. Acute or chronic renal failure (stage III or IV by VARC-3 criteria)

20. Cerebral embolism, stroke, or TIA in past 6 months

21. Myocardial infarction in the past 6 months

22. 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.)

23. Patient had any circulatory, neurovascular, cardiovascular, or neurologic conditions that resulted in unstable neurological symptoms at screening.

24. 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.

25. 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.)

26. Patient had a life expectancy of less than 12 months .

27. Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	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	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

Secondary Outcome Measures

Name	Time	Method
Secondary Safety Endpoints	12 months	Percentage of participants with serious adverse events within the first 30 days after treatment, 6 months and 12 months.
Secondary Effectiveness Endpoints	Day-30, 6-months, and 12-months	Change in mRS between baseline.

Trial Locations

Locations (1)

University Hospital :St. Ivan Rilski"; 🇧🇬 Sophia, Bulgaria