LUMENS-1 EU EFS CIP

Launched by LUSEED VASCULAR LTD. · Dec 31, 2024

Keywords

ClinConnect Summary

The LUMENS-1 clinical trial is studying a new treatment option called the LuSeed Aneurysm Embolization System for individuals with unruptured brain aneurysms. The main goal of the trial is to assess how safe and effective this new device is for patients who need treatment for their aneurysms but have not yet experienced any ruptures. The study will include up to 30 participants from various medical centers in Europe, and to participate, individuals must be between 18 and 80 years old and meet specific health criteria, such as having certain sizes and types of aneurysms that are suitable for the device.

Participants in this trial can expect to undergo a non-emergency procedure to help treat their aneurysm, and they will be closely monitored throughout the process to ensure their safety. It’s important to note that this study is currently recruiting, so interested individuals should check if they meet the eligibility requirements. Overall, this trial aims to provide valuable information about a new treatment option for those with unruptured brain aneurysms, potentially leading to better care in the future.

Gender

ALL

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.