Ischemic Stroke, Acute
Conditions
Keywords
Radial access, Femoral access, Thrombectomy
Brief summary
In patients with suspected acute stroke due to large vessel occlusion with indication for endovascular treatment, radial access is just as safe, fast, and effective as femoral access, and it improves the entire stroke treatment process.
Detailed description
Investigators will compare the procedure times, angiographic results as well as the clinical evolution and the patient's experience during their hospital stay and after discharge, depending on the arterial access practiced for mechanical thrombectomy.
Interventions
PROCEDUREthrombectomy
Extraction of intracranial thrombus in an acute large vessel occlusion
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, prospective clinical trial, under conditions of routine, open-label clinical practice, with the main objective evaluated by an independent investigator who was not blinded to the treatment received. The study will be single-center.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with high suspicion of ischemic stroke due to large cerebral vessel occlusion defined by NIHSS\> 10. * Immediate availability of the entire team responsible for endovascular treatment (Neurologist, Neurointerventional physician, Anesthetist, Nursing, Technicians ...) * Radial artery diameter ≥2.5 mm * Presence of femoral pulse or patency by ultrasonography in its defect. * Previous functional independence (mRS 0-2).
Exclusion criteria
* Life expectancy of less than 6 months. * Intracranial hemorrhage * Patients with pre-existing neurological or psychiatric pathology that may confuse future evaluations. * No availability for follow-up after 90 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No inferiority of radial access in the recanalization rate | Immediate after treatment | To demonstrate the non-inferiority of radial access with respect to femoral access in the recanalization rate (% mTICI 2b-3 in 3 or fewer passes) obtained in patients with large vessel occlusion treated by mechanical thrombectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grades of modified Thrombolysis in Cerebral Infarction | 24 hours | Grade of recanalization after first pass, third pass and at the end of the procedure |
| Change of artery access | 24 hours | Rate of need to change from radial to femoral access and from femoral to radial access |
| Patient Reported Outcomes | 5 days | PROMS Patient Reported Outcomes Measures |
| No differences in complications in vascular access | 24 hours | Comparison in frequency of access vessel occlusion, bleeding or presence of pseudoaneurysm |
| Degree of disability/dependence after a stroke | 24 hours and at 90 days | modified rankin scale (from 0 to 6, being 0 best and 6 worst) |
| Times during hospitalization | At 24 hours and during first 5 days | Beginning of sitting, ambulation, rehabilitation and total time of hospital admission, need for urinary catheter |
| Patient experience | 5 days | PREMS Patient Reported Experience Measures |
Countries
Spain
Contacts
Primary ContactDAVID HERNANDEZ, MD
Backup ContactDAVID HERNANDEZ, MD
Outcome results
None listed