LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan
Key facts
- Where
- Toronto, CanadaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07259018, who can take part
Where in Canada
- St. Michael's Hospital, Unity Health TorontoToronto, CanadaContact: Nitzan HirshNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- LuSeed Vascular LTD.
- Trial code
- NCT07259018
- Record updated
- 9 December 2025
- Original description
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.Read full original descriptionShow less
A Single-arm, Open Label, Single-center Early Feasibility Study of the LuSeed Aneurysm Embolization System in Individuals With Unruptured Intracranial Aneurysms.
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.
Inclusion: 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:; IA located in bifurcation 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 • The AI must meet the definition of a "wide-neck" aneurysm; 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: Target Intracranial aneurysm contains other devices/implants (e.g., coils); Absolute contraindication to anticoagulation or antiplatelet therapy; Anticoagulation medications such as warfarin that cannot be discontinued; 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.); Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes; Known allergy to platinum, nickel, or titanium; Known allergy to contrast agents; Acute or chronic renal failure (stage III or IV by VARC-3 criteria); Cerebral embolism, stroke, or TIA in past 6 months; Myocardial infarction in the past 6 months; Patient had any circulatory, neurovascular, cardiovascular, or neurologic conditions that resulted in unstable neurological symptoms at screening; 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; 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.); Ruptured intracranial aneurysm; Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab; Contraindication for arterial access; Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm; Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm; Intracranial aneurysm minimum height less than 4.0 mm; Stenosis of the target IA's parent vessel >50%; Pregnant, breastfeeding or planning pregnancy within next 12 months; Patient had a life expectancy of less than 12 months.