Stroke Process in FEmoral Versus Radial Access

NCT05225636 | Unknown DMC

• 1 other identifier: PR(AG)209/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Stroke, Acute

Keywords

Radial access; Femoral access; Thrombectomy

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediate after treatment

Secondary Outcomes (7)

• No differences in complications in vascular access

  24 hours

• Grades of modified Thrombolysis in Cerebral Infarction

  24 hours

• Change of artery access

  24 hours

• Patient Reported Outcomes

  5 days

• Patient experience

  5 days

Study Arms (2)

Radial access

ACTIVE COMPARATOR

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

Procedure: thrombectomy

Femoral access

ACTIVE COMPARATOR

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

Procedure: thrombectomy

Interventions

thrombectomy PROCEDURE

Extraction of intracranial thrombus in an acute large vessel occlusion

Femoral access; Radial access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (2)

Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona

Barcelona, 08035, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (17)

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  PMID: 26898852 BACKGROUND

• Saver JL, Goyal M, van der Lugt A, Menon BK, Majoie CB, Dippel DW, Campbell BC, Nogueira RG, Demchuk AM, Tomasello A, Cardona P, Devlin TG, Frei DF, du Mesnil de Rochemont R, Berkhemer OA, Jovin TG, Siddiqui AH, van Zwam WH, Davis SM, Castano C, Sapkota BL, Fransen PS, Molina C, van Oostenbrugge RJ, Chamorro A, Lingsma H, Silver FL, Donnan GA, Shuaib A, Brown S, Stouch B, Mitchell PJ, Davalos A, Roos YB, Hill MD; HERMES Collaborators. Time to Treatment With Endovascular Thrombectomy and Outcomes From Ischemic Stroke: A Meta-analysis. JAMA. 2016 Sep 27;316(12):1279-88. doi: 10.1001/jama.2016.13647.

  PMID: 27673305 BACKGROUND

• Mazighi M, Chaudhry SA, Ribo M, Khatri P, Skoloudik D, Mokin M, Labreuche J, Meseguer E, Yeatts SD, Siddiqui AH, Broderick J, Molina CA, Qureshi AI, Amarenco P. Impact of onset-to-reperfusion time on stroke mortality: a collaborative pooled analysis. Circulation. 2013 May 14;127(19):1980-5. doi: 10.1161/CIRCULATIONAHA.112.000311.

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  PMID: 25791214 BACKGROUND

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  PMID: 18332059 BACKGROUND

• Bertrand OF, Belisle P, Joyal D, Costerousse O, Rao SV, Jolly SS, Meerkin D, Joseph L. Comparison of transradial and femoral approaches for percutaneous coronary interventions: a systematic review and hierarchical Bayesian meta-analysis. Am Heart J. 2012 Apr;163(4):632-48. doi: 10.1016/j.ahj.2012.01.015.

  PMID: 22520530 BACKGROUND

• Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD012318. doi: 10.1002/14651858.CD012318.pub2.

  PMID: 29665617 BACKGROUND

• Ghani MR, Busa V, Dardeir A, Marudhai S, Patel M, Abdelmoneim YM, Jan A, Eskander N. Mechanical Thrombectomy in Patients With Acute Ischemic Stroke: A Comparison of Transradial Versus Transfemoral Cerebral Angiography. Cureus. 2020 Oct 12;12(10):e10919. doi: 10.7759/cureus.10919.

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• Hernandez D, Requena M, Olive-Gadea M, de Dios M, Gramegna LL, Muchada M, Garcia-Tornel A, Diana F, Rizzo F, Rivera E, Rubiera M, Pinana C, Rodrigo-Gisbert M, Rodriguez-Luna D, Pagola J, Carmona T, Juega J, Rodriguez-Villatoro N, Molina C, Ribo M, Tomasello A. Radial Versus Femoral Access for Mechanical Thrombectomy in Patients With Stroke: A Noninferiority Randomized Clinical Trial. Stroke. 2024 Apr;55(4):840-848. doi: 10.1161/STROKEAHA.124.046360. Epub 2024 Feb 1.

  PMID: 38299334 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• ALEJANDRO TOMASELLO, MD

  Hospital Universitari Vall d'Hebron Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DAVID HERNANDEZ, MD

CONTACT

+34934893000; dhm050780@gmail.com

DAVID HERNANDEZ, MD

CONTACT

+34636965667; david.hernandez.idi@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: February 4, 2022
• Study Start: September 15, 2021
• Primary Completion: January 15, 2023
• Study Completion: April 28, 2023
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: After publishing our paper
• Access Criteria: We will share the data for collaborate with other institutions.

Locations

ES (2)