Clinical trial NCT06805721: This Three-year Observational Study Involves Patients of All Ages Undergoing Endovascular Treatment for Various Cerebral or Spinal Vascular Conditions. It Aims to Assess Pre- and Post-operative Clinical Conditions, Report Complications, and Identify Preoperative Indicators of Treatment Outcomes. Pat
Official title: OUTCOME in NEURORADIOLOGIA INTERVENTISTICA INDICAZIONI COMPLICANZE (ONIRIC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysm Cerebral
AVM
DAFV
ESDC
Keywords: Endovascular treatment
Neurospychological assessment
Aneurysm
AVM
Psychological Outcome
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2025-02-03
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients of both sexes and any age who will undergo endovascular treatment and who have signed the specific consent form for participation in the study.

Brief summary: This three-year observational study involves patients of all ages undergoing endovascular treatment for various cerebral or spinal vascular conditions. It aims to assess pre- and post-operative clinical conditions, report complications, and identify preoperative indicators of treatment outcomes. Patients will also receive psychological support and Neuropsychological assessment. Clinical, medical, and demographic data will be recorded in a database during hospitalization and follow-up visits.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes and any age, who are referred to the Department of Neurosurgery and Clinical Neurosciences and are candidates for interventional endovascular procedures for any cerebral or spinal pathology, will be included in the study.

Exclusion Criteria:

* /

Primary outcomes:
measure: Safety and Efficacy of the Endovascular procedures
timeFrame: 1 year after treatment
measure: Landriel-Ibanez Scale
timeFrame: 1 year after treatment
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 1 year after treatment
measure: Modified Rankin Scale (mRS)
timeFrame: 1 year after treatment
measure: Aminoff-Loug Scale
timeFrame: 1 year after treatment
measure: Neursopychological status and Quality of life:
timeFrame: 1 year after treatment
measure: World Health Organization Disability Assessment Schedule (WHODAS):
timeFrame: 1 year after treatment
measure: EQ-5D-5L
timeFrame: 1 year after treatment
measure: State and Traits Anxiety Inventory (STAI)
timeFrame: 1 year after treatment
measure: Beck Depression Inventory (BDI-II)
timeFrame: 1 year after treatment
measure: Coping Orientation to Problems Experienced Inventory (Brief-COPE)
timeFrame: 1 year after treatment
measure: Mini Mental State Examination (MMSE)
timeFrame: 1 year after treatment
measure: Raven Progressive Matrices (RPM)
timeFrame: 1 year after treatment
measure: Ray Auditory Verbal Learning Test (RAVLT)
timeFrame: 1 year after treatment
measure: Rey-Osterrieth Complex Figure (ROCF)
timeFrame: 1 year after treatment
measure: Trail Making Test - A and B (TMT-A-B)
timeFrame: 1 year after treatment
measure: F-A-S Phonemic Verbal Fluency Test
timeFrame: 1 year after treatment
measure: Category Verbal Fluency Test
timeFrame: 1 year after treatment
measure: Verbal Digit Span
timeFrame: 1 year after treatment
measure: Frontal Assessment Battery (FAB)
timeFrame: 1 year after treatment
measure: Stroop Test
timeFrame: 1 year after treatment
Secondary outcomes:
measure: Preprocedural outcome identification
timeFrame: pre-procedure
measure: Socio-demographic variables
timeFrame: pre-procedure
measure: Comorbidities
timeFrame: pre-procedure
measure: Pre-procedure medical treatment
timeFrame: pre-procedure
measure: Morphology of the endovascular pathology
timeFrame: pre-procedure
measure: Dimension in mm
timeFrame: pre-procedure
measure: Location
timeFrame: pre-procedure
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Foundation IRCCS Carlo Besta Neurological Institute
Study officials:
References: