LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan

Официальное название

A Single-arm, Open Label, Single-center Early Feasibility Study of the LuSeed Aneurysm Embolization System in Individuals With Unruptured Intracranial Aneurysms.

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство LuSeed Aneurysm Embolization System
  LuSeed Aneurysm Embolization System EFS Canada

Первичные конечные точки

• Primary Safety Endpoint [Срок оценки: 30 Days Post Study Procedure]
• Primary Feasibility Endpoint [Срок оценки: Day 0]

Вторичные конечные точки (5)

• Secondary Safety Endpoints [Срок оценки: 12 months]
• Secondary Safety Endpoints [Срок оценки: 12 months]
• Secondary Safety Endpoints [Срок оценки: 12 months]
• Secondary Effectiveness Endpoints [Срок оценки: 6-months and 12-months after treatment]
• Secondary Effectiveness Endpoints [Срок оценки: Day-30, 6-months and 12-months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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
• Target Intracranial aneurysm contains other devices/implants (e.g., coils)
• Stenosis of the target IA's parent vessel >50%
• Known allergy to platinum, nickel, or titanium
• Known allergy to contrast agents
• Absolute contraindication to anticoagulation or antiplatelet therapy
• Anticoagulation medications such as warfarin that cannot be discontinued
• Pregnant, breastfeeding or planning pregnancy within next 12 months
• 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
• 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.)
• 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.)
• Patient had a life expectancy of less than 12 months.
• Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Канада · 1 центр

• St. Michael's Hospital - Unity Health Toronto — Toronto

Публикации

• 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 PMID 16139655
• 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. PMID 19461057
• Keedy A. An overview of intracranial aneurysms. Mcgill J Med. 2006 Jul;9(2):141-6. PMID 18523626
• 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/ PMID 32491790
• 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.

Идентификаторы

NCT: NCT07259018 · PRT-0000357

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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