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 (ONIRIC)

OUTCOME IN NEURORADIOLOGIA INTERVENTISTICA INDICAZIONI COMPLICANZE (ONIRIC)

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.

Study Overview

• Status: Recruiting
• Conditions: AVM; Aneurysm Cerebral; DAFV; ESDC

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Elisa Ciceri, M.D.; Phone Number: 02.2394.2411-2412; Email: elisa.ciceri@istituto-besta.it
• Study Contact Backup: Name: Matteo Milani, M.D.; Phone Number: 02.2394.2411-2412; Email: matteo.milani@istituto-besta.it

Study Locations

• Italy
  • Milan, Italy, 20133
    • Recruiting
    • Foundation IRCCS Carlo Besta Neurological Institute
    • Contact: Elisa Ciceri, MD; Phone Number: 02.2394.2411-2412; Email: elisa.ciceri@istituto-besta.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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:

• /

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Efficacy of the Endovascular procedures	Describe the safety and efficacy of endovascular procedures performed for cerebro-spinal vascular diseases or hypervascularized lesions treated in the institute either through endovascular means or direct puncture. In order to the describe safety and efficay, the analysis will report the number and the nature of clinical and technical adverse events related or unrelated to a device deficiency, as assessed by CTCAE v4.0. Moreover ther will be a qualitative and quantitive (Landriel-Ibanez scale) report of the complications, and the clinical outcomes (NIHSS, mRS, Aminoff-Loug scale).	1 year after treatment
Landriel-Ibanez Scale	Assesses functional outcome and recovery in patients, often after neurological injuries or interventions. Scores range from 0 to 4: 0 indicates no deficits, while higher scores indicate worse functional outcomes or greater levels of disability.	1 year after treatment
National Institutes of Health Stroke Scale (NIHSS)	Quantifies the severity of neurological impairment in stroke patients, focusing on motor, sensory, language, and visual deficits. Scores range from 0 to 42: 0 indicates no neurological deficits, Scores 1-4 Minor stroke, Scores 5-15 Moderate stroke, Scores 16-20 Moderate-to-severe stroke, Scores 21-42 Severe stroke. Higher scores indicate greater stroke severity.	1 year after treatment
Modified Rankin Scale (mRS)	Assesses the degree of disability or dependence in daily activities after a stroke or other neurological conditions. Scores range from 0 to 6, with higher scores indicate worse outcomes or greater levels of disability.	1 year after treatment
Aminoff-Loug Scale	Evaluates functional impairments. It focuses on mobility and dependency in activities of daily living. Scores range from 0 to 5 with higher scores reflecting increasing disability and dependence in daily living activities.	1 year after treatment
Neursopychological status and Quality of life:	Describe the neuropsychological status and quality of life of the patient before and after (3month/6month Follow-Up and 1 year Follow-Up) the execution of such procedures. The goal is to better understand if there will be a significative change regarding such variables. The questionnaire and tests used for such assessment are listed below.	1 year after treatment
World Health Organization Disability Assessment Schedule (WHODAS):	Assesses disability and impairment in various life domains, with score ranging fro 0 to 100, where higher scores indicate higher disability. This scale will be part of the quality of life assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
EQ-5D-5L	Assesses health-related quality of life across five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each domain has a score range fro 1 to five, where higher scores reflect lower quality of life. The VAS (Visual Analogue Scale) can be used as a quantitative measure of health outcome that reflects the patient's own judgement, with a score range from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine"). This scale will be part of the quality of life assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
State and Traits Anxiety Inventory (STAI)	Assesses anxiety in two dimensions: state anxiety (temporary and situation-specific) and trait anxiety (a stable characteristic). Each dimension ranges from 20 to 80, with Higher scores indicate higher levels of anxiety. This scale will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
Beck Depression Inventory (BDI-II)	Evaluates the severity of depressive symptoms. Score ranges from 0 to 63, higher scores indicate more severe depression. This scale will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
Coping Orientation to Problems Experienced Inventory (Brief-COPE)	Evaluates coping strategies in response to stress. Each subscale ranges from 2 to 8, with different strategies assessed (e.g., active coping, avoidance), Scores indicate the extent to which specific coping strategies are used, with no direct "better" or "worse. This scale will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
Mini Mental State Examination (MMSE)	Assessing generic cognitive function. Raw scores range from 0 to 30, according to Maesso 1993 and Magni 1996, with higher scores indicating better cognitive fuctioning. The raw score are corrected by age and educationT This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
Raven Progressive Matrices (RPM)	Assees Nonverbal reasoning and problem-solving abilities. Raw Scores, according to the version of Carlesimo et. Al. 1995, range from 0 to 36, then corrected by eduction and age and converted toequivalent scores. Higher scores means better perfomance. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
Ray Auditory Verbal Learning Test (RAVLT)	Assesses verbal learning and memory. Higher scores indicate better memory performance, with lerning scores range fro 0 to 75 and log term memory from 0 to 15. Raw scores, according to the version of Carlesimo et. Al. 1996, are then corrected by age and education and converted into equivalent scores. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
Rey-Osterrieth Complex Figure (ROCF)	Assesses visuospatial ability, memory, and planning through figure reproduction and recall. Raw scores range from 0 to 36 for both reproduction and recall and, according to the version of Caffarra et. Al. 2002, are then corrected by education and age and converted to equivalent scores. Higher scores indicate better visuospatial and memory performance. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
Trail Making Test - A and B (TMT-A-B)	Measures visual attention, task-switching, and processing speed (TMT-A: sequencing numbers; TMT-B: alternating between numbers and letters). The score is determined by the time used to complete the tasks, the higher it is the poorer is the performance. Raw time scores are then corrected by age and education and then converted into equivalent scores, according to the version of Giovagnoli et al.1996. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
F-A-S Phonemic Verbal Fluency Test	Assesses verbal fluency by generating words starting with specific letters (e.g., F, A, S) within 60 seconds. The higher is the number of words produced, the higher the performance. The raw score is then corrected by age and education and then converted into equivalent scores, according to the version of Carlesimo et al. 1995. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
Category Verbal Fluency Test	Assesses semantic verbal fluency by generating words within specific categories (e.g., animals) in 60 seconds. The higher is the number of words produced, the higher the performance. The raw score, the number of words produced in the set time, is then corrected by age and education and then converted into equivalent scores, according to the version of Carlesimo et al. 1995. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).	1 year after treatment
Verbal Digit Span	Assesses short term memoty (forward) and workin memory (backward). The score is determined by the amount of numers that the patiente reports correctly (span). The raw score is then corrected by age and education and then converted into equivalent scores, according to the version of Monaco et al. 2012.	1 year after treatment
Frontal Assessment Battery (FAB)	Assesses various executive function (Conceptualization, Mental flexibility, Motor programming, Sensitivity to interference, Inhibitory control and environmental autonomy). For each dimension the score range is from 0 to 3, resulting in a total score of 18. The raw score is then corrected by age and education and then converted into equivalent scores, according to the version of Apollnio et al. 2005.	1 year after treatment
Stroop Test	The test consist of three different parts (words, color and word-color) and assesses processing speed, attention and inhibitory control. The performance is determined by time and errrors in completing the task. Both time and errors raw scores, after being processed through the dedicated formula, are then corrected by age and education and the converted in equivalent scores, according to Cafarra et al. 2002.	1 year after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preprocedural outcome identification	Identify the pre-procedural indicators of outcome in the various treated pathologies. The analysis will include a report of the possible association between the pre procedural indicators (socio-demographic variables, comorbidities, pre-procedure medical treatment, morphology, dimension and location of the endovascular pathology) and the clinical and neuropsychological outcome describe above.	pre-procedure
Socio-demographic variables	Age in years, Sex, education in years	pre-procedure
Comorbidities	Hypertension, smoker, diabete, familiarity with endovascular pathololgies.	pre-procedure
Pre-procedure medical treatment	It will be reported if the patient will be in single antiplatelet or dual antiplatelet medication before the procedure and the wich drug is used.	pre-procedure
Morphology of the endovascular pathology	In case of aneurysm, it will report the if the morphology is saccular, dissecant, ovalar, fusiform, with a large or a small collar. In case of MAV, the morphology will be described using the Spetzler-Martin scale(0-5 points): size (0-3 points, venous drainage (0-1 point), eloquent brain areas (0-1 point), grading (0-1 Point).	pre-procedure
Dimension in mm	It will report the dimension of the pathology (AVMS, SDH, Aneurysm, FAVD, FAVDs)	pre-procedure
Location	The location will include the hemisphere side (left, right, bilateral) and the information about witch artery/vein is involved in the pathology.	pre-procedure

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Aneurysm; AVM; Endovascular treatment; Neurospychological assessment; Psychological Outcome
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: ONIRIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No