LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

LuSeed Vascular LTD.

Status: Not yet enrolling

Conditions: Brain Aneurysm; Aneurysm Cerebral; Saccular Aneurysm; Unruptured Intracranial Aneurysm; Bifurcation

Treatments: Device: LuSeed Aneurysm Embolization System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07259018

PRT-0000357

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

LuSeed Aneurysm Embolization System

Experimental group

Treatment:

Device: LuSeed Aneurysm Embolization System