Stroke Process in FEmoral Versus Radial Access

Not Applicable

• Conditions: Ischemic Stroke, Acute
• Interventions: Procedure: thrombectomy

• Registration Number: NCT05225636
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Timeline

• Study First Submitted: 2021-08-27
• Study Start: 2021-09-15
• Status Verified: 2022-01
• Study First Submitted QC: 2022-02-03
• Last Update Submitted: 2022-02-03
• Study First Posted: 2022-02-04
• Last Update Posted: 2022-02-04
• Primary Completion: 2023-01-15
• Study Completion: 2023-04-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral access	thrombectomy	The ischemic stroke treatment will be performed through the femoral artery (as first option)
Radial access	thrombectomy	The ischemic stroke treatment will be performed through the radial artery (as first option)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change of artery access	24 hours	Rate of need to change from radial to femoral access and from femoral to radial access
Grades of modified Thrombolysis in Cerebral Infarction	24 hours	Grade of recanalization after first pass, third pass and at the end of the procedure
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
No differences in complications in vascular access	24 hours	Comparison in frequency of access vessel occlusion, bleeding or presence of pseudoaneurysm
Patient Reported Outcomes	5 days	PROMS Patient Reported Outcomes Measures
Patient experience	5 days	PREMS Patient Reported Experience Measures
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)

Trial Locations

Locations (2)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona; 🇪🇸 Barcelona, Spain