Evaluating a new embolization system for unruptured brain aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation aims to assess the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms. It is a prospective, single-arm, open-label, multi-center study that will enroll up to 30 eligible patients across a maximum of 10 medical centers in the EU. Participants will be screened based on national or international guidelines and must meet specific inclusion and exclusion criteria to qualify for the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital St. Ivan Rilski
  Sofia, Bulgaria Recruiting
• The University Medical Center Hamburg-Eppendorf
  Hamburg, Germany Recruiting
• Sheba Medical Center
  Tel HaShomer, Israel Recruiting
• UCK Katowice
  Katowice, Poland Recruiting
• Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
  Lodz, Poland Recruiting
• Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
  Wroclaw, Poland Not yet recruiting

Study contacts

• Principal investigator: Vitor Pereira, MD MSc
• Study coordinator: Nitzan Hirsh
• Email: Nitzan.h@luseed-vascular.com
• Phone: 972-545333200

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.