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NCT07864389
Multimodal Approach Feasability Study for Untreated and Unruptured Intracranial Aneurysms
Conditions: Aneurysm Cerebral (Unruptured)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Resolve Stroke
Location: Nantes University Hospital Nantes
Summary
This feasibility study aims to evaluate the SYLVER system's ability to visualize intracranial aneurysms in accordance with 3D rotational angiography (3DRA) as the reference technique.
Eligibility Criteria
Inclusion Criteria:
* Adult patients (≥ 18 years of age)
* Informed consent signed by the patient
* Enrolled in a social security program or covered by an equivalent program
* Presence of one or more unruptured, untreated intracranial aneurysms; typically bifurcation aneurysms, incidentally discovered, with a size of ≥ 3 mm; located at the base of the polygon of Willis in the Sylvian bifurcation, the anterior or posterior communicating artery, or the carotid or basilar terminal segments
* Indications for diagnostic cerebral arteriography within a 6-month period following the discovery of one or more unruptured aneurysms
Exclusion Criteria:
* Unusable temporal window
* Withdrawal of Consent by the Patient
* Cancellation of the appointment for a cerebral angiography
* At the investigator's initiative, in the patient's best interest
Source: ClinicalTrials.gov (NCT07864389). StuddyBuddy aggregates publicly available trial information.