Clinical trial NCT05225636: Stroke Process in FEmoral Versus Radial Access
Official title: Stroke Process in FEmoral Versus Radial Access
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Stroke, Acute
Keywords: Radial access
Femoral access
Thrombectomy
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: No inferiority of radial access in the recanalization rate
timeFrame: Immediate after treatment
Secondary outcomes:
measure: No differences in complications in vascular access
timeFrame: 24 hours
measure: Grades of modified Thrombolysis in Cerebral Infarction
timeFrame: 24 hours
measure: Change of artery access
timeFrame: 24 hours
measure: Patient Reported Outcomes
timeFrame: 5 days
measure: Patient experience
timeFrame: 5 days
measure: Degree of disability/dependence after a stroke
timeFrame: 24 hours and at 90 days
measure: Times during hospitalization
timeFrame: At 24 hours and during first 5 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
Study officials:
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: ALEJANDRO TOMASELLO, MD
role: PRINCIPAL_INVESTIGATOR
References:
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