About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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).
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.
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.
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.
Secondary outcomes
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.
Socio-demographic variables
Age in years, Sex, education in years
Comorbidities
Hypertension, smoker, diabete, familiarity with endovascular pathololgies.
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.
Sponsors and contacts
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