Stroke Process in FEmoral Versus Radial Access

Hospital Universitari Vall d'Hebron Research Institute100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Ischemic Stroke, Acute

Interventions

thrombectomyPROCEDURE

Extraction of intracranial thrombus in an acute large vessel occlusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Barcelona, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Immediate after treatment

Secondary Outcomes

No differences in complications in vascular access

Comparison in frequency of access vessel occlusion, bleeding or presence of pseudoaneurysm

Time frame: 24 hours

Grades of modified Thrombolysis in Cerebral Infarction

Grade of recanalization after first pass, third pass and at the end of the procedure

Time frame: 24 hours

Change of artery access

Rate of need to change from radial to femoral access and from femoral to radial access

Time frame: 24 hours

Patient Reported Outcomes

PROMS Patient Reported Outcomes Measures

Time frame: 5 days

Patient experience

PREMS Patient Reported Experience Measures

Time frame: 5 days

Degree of disability/dependence after a stroke

modified rankin scale (from 0 to 6, being 0 best and 6 worst)

Time frame: 24 hours and at 90 days

Times during hospitalization

Beginning of sitting, ambulation, rehabilitation and total time of hospital admission, need for urinary catheter

Central Contacts

DAVID HERNANDEZ, MD

CONTACT

+34934893000 dhm050780@gmail.com

DAVID HERNANDEZ, MD

CONTACT

+34636965667 david.hernandez.idi@gencat.cat

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.