Menu
Recruiting NCT06761365

LUMENS-1 EU EFS CIP

No phase Interventional Aneurysm Cerebral Bifurcation Unruptured Intracranial Aneurysm Saccular Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LuSeed Aneurysm Embolization System.
Who it may be relevant to
Registry conditions: Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Bulgaria, Germany, Israel, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A SINGLE-ARM, OPEN LABEL, MULTI-CENTER EARLY FEASIBILITY STUDY OF THE LUSEED ANEURYSM EMBOLIZATION SYSTEM IN INDIVIDUALS WITH UPRUPTURED INTRACRANIAL ANEURYSMS

Overview

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 prospective, single-arm, open-label, multi-center, interventional study, screening patients approved for treatment of unruptured IAs based on national or international guidelines. Up to 30 eligible subjects meeting inclusion and exclusion criteria and providing consent will be enrolled across a maximum of 10 medical centers in the EU.

Detailed description

LuSeed Vascular is sponsoring a prospective, multi-center single arm clinical trial enrollment initiated on October 2024 to assess early safety and feasibility of the LuSeed Aneurysm Embolization System for the treatment of unruptured intracranial aneurysms (IA).

Interventions

  • Device LuSeed Aneurysm Embolization System
    a permanent intrasaccular implant used for treatment of unruptured intracranial saccular aneurysms (IA) in adult patients according to international guidelines who are indicated for non-emergent endovascular embolization of saccular IAs at the time of presentation.

Primary outcome measures

  • Primary Safety Endpoint [Time frame: 30 Days Post Study Procedure]
  • Primary Feasibility Endpoint [Time frame: Day 0]
Secondary outcome measures (5)
  • Secondary Safety Endpoints [Time frame: 12 months]
  • Secondary Safety Endpoints [Time frame: 12 months]
  • Secondary Safety Endpoints [Time frame: 12 months]
  • Secondary Effectiveness Endpoints [Time frame: 6-months and 12-months after treatment]
  • Secondary Effectiveness Endpoints [Time frame: Day-30, 6-months, and 12-months]

Eligibility criteria

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:
  • IA located 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 4. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements Exclusion Criteria: 5. Patient able to give their informed consent can be included in this study. Exclusion Criteria
  • 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
  • Intracarnial aneurysm minimum hight 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Poland · 3 centers
  • UCK Katowice — Katowice
  • Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz — Lodz
  • Jan Mikulicz-Radecki University Clinical Hospital in Wrocław — Wroclaw
Bulgaria · 1 center
  • University Hospital St. Ivan Rilski — Sofia
Germany · 1 center
  • The University Medical Center Hamburg-Eppendorf — Hamburg
Israel · 1 center
  • Sheba Medical Center — Tel Litwinsky

Publications

  • 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.

Identifiers

NCT: NCT06761365 · PRT-0000264

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗