Clincosm LogoSign in Get a demo

SFERA: Stroke Process in FEmoral Versus Radial Access

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05225636
Collaborator
(none)
100
Enrollment
2
Locations
2
Arms
19.4
Anticipated Duration (Months)
50
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: thrombectomy
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Stroke Process in FEmoral Versus Radial Access
Actual Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Jan 15, 2023
Anticipated Study Completion Date :
Apr 28, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. No differences in complications in vascular access [24 hours]

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

  2. Grades of modified Thrombolysis in Cerebral Infarction [24 hours]

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

  3. Change of artery access [24 hours]

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

  4. Patient Reported Outcomes [5 days]

    PROMS Patient Reported Outcomes Measures

  5. Patient experience [5 days]

    PREMS Patient Reported Experience Measures

  6. 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)

  7. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona Barcelona Spain 08035
2 Hospital Universitari Vall d'Hebron Barcelona Spain 08035

Sponsors and Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT05225636
Other Study ID Numbers:
  • PR(AG)209/2021
First Posted:
Feb 4, 2022
Last Update Posted:
Feb 4, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute
Radial access
Femoral access
Thrombectomy
Additional relevant MeSH terms:
Stroke
Ischemic Stroke

Study Results

No Results Posted as of Feb 4, 2022