LUMENS-1 EU EFS CIP
Recruiting now · Not applicable
Conditions studied: Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm, Brain Aneurysm
In brief
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.
Key facts
- Study ID
- NCT06761365
- Run by
- LuSeed Vascular LTD.
- People needed
- 30
- Starts
- 2024-10-07
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-11-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify 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
- 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
Where it is running
- University Hospital St. Ivan Rilski — Sofia, Bulgaria (enrolling)
- The University Medical Center Hamburg-Eppendorf — Hamburg, Germany (enrolling)
- Sheba Medical Center — Tel Litwinsky, Israel (enrolling)
- UCK Katowice — Katowice, Poland (enrolling)
- Norbert Barlicki Memorial Teaching Hospital No. 1 of the Medical University of Lodz — Lodz, Poland (enrolling)
- Jan Mikulicz-Radecki University Clinical Hospital in Wrocław — Wroclaw, Poland
Full record on ClinicalTrials.gov
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