Stroke Process in FEmoral Versus Radial Access (SFERA)

February 3, 2022 updated by: Hospital Universitari Vall d'Hebron Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Radial access
The ischemic stroke treatment will be performed through the radial artery (as first option)
Procedure: thrombectomy
Extraction of intracranial thrombus in an acute large vessel occlusion
Active Comparator: Femoral access
The ischemic stroke treatment will be performed through the femoral artery (as first option)
Procedure: thrombectomy
Extraction of intracranial thrombus in an acute large vessel occlusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No inferiority of radial access in the recanalization rate
Time Frame: 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.
Immediate after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No differences in complications in vascular access
Time Frame: 24 hours
Comparison in frequency of access vessel occlusion, bleeding or presence of pseudoaneurysm
24 hours
Grades of modified Thrombolysis in Cerebral Infarction
Time Frame: 24 hours
Grade of recanalization after first pass, third pass and at the end of the procedure
24 hours
Change of artery access
Time Frame: 24 hours
Rate of need to change from radial to femoral access and from femoral to radial access
24 hours
Patient Reported Outcomes
Time Frame: 5 days
PROMS Patient Reported Outcomes Measures
5 days
Patient experience
Time Frame: 5 days
PREMS Patient Reported Experience Measures
5 days
Degree of disability/dependence after a stroke
Time Frame: 24 hours and at 90 days
modified rankin scale (from 0 to 6, being 0 best and 6 worst)
24 hours and at 90 days
Times during hospitalization
Time Frame: At 24 hours and during first 5 days
Beginning of sitting, ambulation, rehabilitation and total time of hospital admission, need for urinary catheter
At 24 hours and during first 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Investigators

  • Principal Investigator: ALEJANDRO TOMASELLO, MD, Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Anticipated)

January 15, 2023

Study Completion (Anticipated)

April 28, 2023

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

February 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)209/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After finishing the study we will share all the data if a collaboration is proposed

IPD Sharing Time Frame

After publishing our paper

IPD Sharing Access Criteria

We will share the data for collaborate with other institutions.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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