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New treatment option for Aneurysm Cerebral
Official title LUMENS-1 EU EFS CIP
ClinicalTrials.gov ID: NCT06761365
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Sofia, Bulgaria
- Hamburg, Germany
- Tel Litwinsky, Israel
- Katowice, Poland
- Lodz, Poland
- Wroclaw, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sofia, Bulgaria; Hamburg, Germany; Tel Litwinsky, Israel; Katowice, Poland; Lodz, Poland; Wroclaw, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.