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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 single-arm, open-label, single-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 10 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled in a Canadian site.
LuSeed Vascular will sponsor the study and the study will assess early safety and feasibility of the LuSeed Aneurysm Embolization System for the treatment of unruptured intracranial aneurysms (IA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LuSeed Aneurysm Embolization System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LuSeed Aneurysm Embolization System | Device | LuSeed Aneurysm Embolization System EFS Canada |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | 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 | 30 Days Post Study Procedure |
| Primary Feasibility Endpoint | Technical Success as defined by: a. Success in accessing target intracranial aneurysm (IA) with the LuSeed Aneurysm Embolization System b. Successful visual confirmation of the LuSeed Aneurysm Embolization System Successful deployment and detachment of the LuSeed Aneurysm Embolization System | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Endpoints | Percentage of participants with death of non-accidental cause or device related death, or major disabling stroke at 6 months and 12 months. | 12 months |
| Secondary Safety Endpoints |
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Inclusion Criteria:
Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
Age 18-80 years at screening
Patients who are suitable for non-emergency endovascular embolization of saccular IAs
The IA must have had the following characteristics:
Use (IFU) and as follows:
Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements
Patient able to give their informed consent can be included in this study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitzan Hirsh | Contact | +972-545333200 | Nitzan.h@luseed-vascular.com | |
| Gali Vino | Contact | +972-525527565 | galiv@luseed-vascular.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Michael's Hospital - Unity Health Toronto | Toronto | Ontario | M5C 1R6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16139655 | Background | Molyneux AJ, Kerr RS, Yu LM, Clarke M, Sneade M, Yarnold JA, Sandercock P; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International subarachnoid aneurysm trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised comparison of effects on survival, dependency, seizures, rebleeding, subgroups, and aneurysm occlusion. Lancet. 2005 Sep 3-9;366(9488):809-17. doi: 10.1016/S0140-6736(05)67214-5. | |
| 19461057 |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Percentage of participants presenting each component of the safety composite within first 30 days after treatment, 6 months and 12 months
| 12 months |
| Secondary Safety Endpoints | Percentage of participants with serious adverse events within the first 30 days after treatment, 6 months and 12 months. | 12 months |
| Secondary Effectiveness Endpoints | Proportion of subjects with Complete Aneurysm Occlusion immediate post procedure. | 6-months and 12-months after treatment |
| Secondary Effectiveness Endpoints | Change in mRS between baseline. | Day-30, 6-months and 12-months |
| Background |
| 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. |
| 18523626 | Background | Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6. |
| 32491790 | Background | Faluk M, Das JM, De Jesus O. Saccular Aneurysm. 2024 Mar 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557867/ |
| Background | 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. |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |