Stroke Process in FEmoral Versus Radial Access

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stroke Process in FEmoral Versus Radial Access

Conditions
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Ischemic Stroke, Acute

Intervention / Treatment
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* Procedure: thrombectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radial access<br>The ischemic stroke treatment will be performed through the radial artery (as first option) | Procedure: thrombectomy<br>* Extraction of intracranial thrombus in an acute large vessel occlusion<br>|
| Active Comparator: Femoral access<br>The ischemic stroke treatment will be performed through the femoral artery (as first option) | Procedure: thrombectomy<br>* Extraction of intracranial thrombus in an acute large vessel occlusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No inferiority of radial access in the recanalization rate | 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. | Immediate after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No differences in complications in vascular access | Comparison in frequency of access vessel occlusion, bleeding or presence of pseudoaneurysm | 24 hours | 
| Grades of modified Thrombolysis in Cerebral Infarction | Grade of recanalization after first pass, third pass and at the end of the procedure | 24 hours | 
| Change of artery access | Rate of need to change from radial to femoral access and from femoral to radial access | 24 hours | 
| Patient Reported Outcomes | PROMS Patient Reported Outcomes Measures | 5 days | 
| Patient experience | PREMS Patient Reported Experience Measures | 5 days | 
| Degree of disability/dependence after a stroke | modified rankin scale (from 0 to 6, being 0 best and 6 worst) | 24 hours and at 90 days | 
| Times during hospitalization | Beginning of sitting, ambulation, rehabilitation and total time of hospital admission, need for urinary catheter | At 24 hours and during first 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial access, Femoral access, Thrombectomy