Stroke Process in FEmoral Versus Radial Access (SFERA)

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Ischemic Stroke, Acute

Treatments: Procedure: thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05225636

PR(AG)209/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Radial access

Active Comparator group

Description:

The ischemic stroke treatment will be performed through the radial artery (as first option)

Treatment:

Procedure: thrombectomy

Femoral access

Active Comparator group

Description:

The ischemic stroke treatment will be performed through the femoral artery (as first option)

Treatment:

Procedure: thrombectomy