Stroke Process in FEmoral Versus Radial Access

NCT ID: NCT05225636

Last Updated: 2022-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-15

Study Completion Date

2023-04-28

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.

Conditions

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Ischemic Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radial access

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

Group Type ACTIVE_COMPARATOR

thrombectomy

Intervention Type PROCEDURE

Extraction of intracranial thrombus in an acute large vessel occlusion

Femoral access

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

Group Type ACTIVE_COMPARATOR

thrombectomy

Intervention Type PROCEDURE

Extraction of intracranial thrombus in an acute large vessel occlusion

Interventions

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thrombectomy

Extraction of intracranial thrombus in an acute large vessel occlusion

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ALEJANDRO TOMASELLO, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitari Vall d'Hebron Research Institute

Locations

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Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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DAVID HERNANDEZ, MD

Role: CONTACT

+34934893000 ext. 6441

DAVID HERNANDEZ, MD

Role: CONTACT

+34636965667

Facility Contacts

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Alejandro Tomasello, MD

Role: primary

934893000 ext. 6441

Alejandro Tomasello, MD

Role: primary

93489300 ext. 6441

David Hernandez, MD

Role: backup

93489300 ext. 6748

References

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Reference Type DERIVED
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Other Identifiers

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PR(AG)209/2021

Identifier Type: -

Identifier Source: org_study_id

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