Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-10-07
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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The study population includes adult patients with an unruptured intracranial saccular aneurysms (IA)
All eligible patients who underwent an attempt with the LuSeed Aneurysm Embolization System.
LuSeed Aneurysm Embolization System
a permanent intrasaccular implant used for treatment of unruptured intracranial saccular aneurysms (IA) in adult patients according to international guidelines who are indicated for non-emergent endovascular embolization of saccular IAs at the time of presentation.
Interventions
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LuSeed Aneurysm Embolization System
a permanent intrasaccular implant used for treatment of unruptured intracranial saccular aneurysms (IA) in adult patients according to international guidelines who are indicated for non-emergent endovascular embolization of saccular IAs at the time of presentation.
Eligibility Criteria
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Inclusion Criteria
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\[mm\]
Exclusion Criteria
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.
18 Years
80 Years
ALL
No
Sponsors
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LuSeed Vascular LTD.
INDUSTRY
Responsible Party
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Principal Investigators
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Vitor Pereira, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Locations
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University Hospital St. Ivan Rilski
Sofia, , Bulgaria
The University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Sheba Medical Center
Tel Litwinsky, , Israel
UCK Katowice
Katowice, , Poland
Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz
Lodz, , Poland
Jan Mikulicz-Radecki University Clinical Hospital in Wrocław
Wroclaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
References
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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.
Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6.
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/
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.
Other Identifiers
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PRT-0000264
Identifier Type: -
Identifier Source: org_study_id
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