LUMENS-1 EU EFS CIP
Recruiting
N/A
Interventional Study
Aneurysm Cerebral
Bifurcation
Unruptured Intracranial Aneurysm
Saccular Aneurysm
Brain Aneurysm
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 30 (estimated)
- Sponsor
- LuSeed Vascular LTD. · Industry
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About This Trial
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 elig…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines.
1. Age 18-80 years at screening
2. Patients who are suitable for non-emergency endovascular embolization of saccular IAs
3. The IA must have had the following c…
Contacts