LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2028-05-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Aneurysm Cerebral Bifurcation Unruptured Intracranial Aneurysm Saccular Aneurysm Brain Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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LuSeed Aneurysm Embolization System

Group Type EXPERIMENTAL

LuSeed Aneurysm Embolization System

Intervention Type DEVICE

LuSeed Aneurysm Embolization System EFS Canada

Interventions

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LuSeed Aneurysm Embolization System

LuSeed Aneurysm Embolization System EFS Canada

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
2. Age 18-80 years at screening
3. Patients who are suitable for non-emergency endovascular embolization of saccular IAs
4. 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.
5. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements
6. 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. Intracranial aneurysm minimum height 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No