LUMENS-1 EU EFS CIP

LuSeed Vascular LTD.

Status

Enrolling

Conditions

Brain Aneurysm

Aneurysm Cerebral

Saccular Aneurysm

Unruptured Intracranial Aneurysm

Bifurcation

Treatments

Device: LuSeed Aneurysm Embolization System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06761365

PRT-0000264

Details and patient eligibility

About

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.

Full 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).

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.