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Stroke Process in FEmoral Versus Radial Access (SFERA)

Primary Purpose

Ischemic Stroke, Acute

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

thrombectomy

About this trial

This is an interventional treatment trial for Ischemic Stroke, Acute focused on measuring Radial access, Femoral access, Thrombectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hospital Universitari Vall d'Hebron. Universitat Autonoma de BarcelonaRecruiting
Hospital Universitari Vall d'HebronRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Radial access

Femoral access

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

No differences in complications in vascular access

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

Grades of modified Thrombolysis in Cerebral Infarction

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

Change of artery access

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

Patient Reported Outcomes

PROMS Patient Reported Outcomes Measures

Patient experience

PREMS Patient Reported Experience Measures

Degree of disability/dependence after a stroke

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

Times during hospitalization

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

Full Information

NCT ID

NCT05225636

First Posted

August 27, 2021

Last Updated

February 3, 2022

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05225636

Brief Title

Stroke Process in FEmoral Versus Radial Access

Acronym

SFERA

Official Title

Stroke Process in FEmoral Versus Radial Access

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2021 (Actual)

Primary Completion Date

January 15, 2023 (Anticipated)

Study Completion Date

April 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Acute

Keywords

Radial access, Femoral access, Thrombectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radial access

Arm Type

Active Comparator

Arm Description

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

Arm Title

Femoral access

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

thrombectomy

Intervention Description

Extraction of intracranial thrombus in an acute large vessel occlusion

Primary Outcome Measure Information:

Title

No inferiority of radial access in the recanalization rate

Description

Time Frame

Immediate after treatment

Secondary Outcome Measure Information:

Title

No differences in complications in vascular access

Description

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

Time Frame

24 hours

Title

Grades of modified Thrombolysis in Cerebral Infarction

Description

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

Time Frame

24 hours

Title

Change of artery access

Description

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

Time Frame

24 hours

Title

Patient Reported Outcomes

Description

PROMS Patient Reported Outcomes Measures

Time Frame

5 days

Title

Patient experience

Description

PREMS Patient Reported Experience Measures

Time Frame

5 days

Title

Degree of disability/dependence after a stroke

Description

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

Time Frame

24 hours and at 90 days

Title

Times during hospitalization

Description

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

Time Frame

At 24 hours and during first 5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

DAVID HERNANDEZ, MD

Phone

+34934893000

Ext

6441

dhm050780@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

DAVID HERNANDEZ, MD

Phone

+34636965667

david.hernandez.idi@gencat.cat

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ALEJANDRO TOMASELLO, MD

Organizational Affiliation

Hospital Universitari Vall d'Hebron Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alejandro Tomasello, MD

Phone

934893000

Ext

6441

alejandrotomasello@gmail.com

Facility Name

Hospital Universitari Vall d'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alejandro Tomasello, MD

Phone

93489300

Ext

6441

alejandrotomasello@gmail.com

First Name & Middle Initial & Last Name & Degree

David Hernandez, MD

Phone

93489300

Ext

6748

dhm050780@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

26898852

Citation

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Stroke Process in FEmoral Versus Radial Access

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