Acceso braquial versus femoral para la colocación de stent en la arteria carótida (BEFIT)
Acceso braquial versus femoral para colocación de stent en la arteria carótida: un ensayo clínico aleatorizado multicéntrico (BEFIT)
Study purpose:
A multicenter, prospective and randomized study is planned to compare the clinical outcomes of carotid artery stenting via brachial artery access and femoral artery access.
Eligible participants will be randomly assigned 1:1 to the brachial artery group or the femoral artery group.
Primary endpoint: surgical success rate.
Secondary endpoints:
- Operation time (time from first arterial puncture to last angiography)
- Serious adverse events (SAE) within 90 days;
- Access puncture complications;
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
With the improvement of treatment concepts and the continuous innovation of interventional devices/interventional technologies, neurointervention has become the preferred treatment method for many cerebrovascular diseases. Among them, the femoral artery is the most commonly used access, because the femoral artery is superficial, easy to touch, and the relatively large vessel diameter allows most neurointerventional surgeries to proceed smoothly. However, the femoral artery access also has the disadvantages of long bed rest time, exposure to private parts, and prolonged hospitalization.
Thanks to the great success of radial artery access in cardiac intervention, radial artery access is increasingly being used in neurointervention. However, due to the thin radial artery, there is a significantly increased risk of complications (radial artery spasm, radial artery occlusion) during large-cavity nerve intervention, and the operation time is significantly prolonged. Therefore, the overall proportion of neurointerventional treatment via radial artery access in clinical practice is less than 12%.
As the superior vascular trunk of the radial artery, the brachial artery has a larger diameter and is theoretically more suitable to replace the radial artery for large-bore intervention. Anatomically, the brachial artery is superficial and easy to touch in the antecubital fossa, and there are no important vessels and nerves in front of the blood vessel, and the posterior is the distal humeral platform, which is easy for brachial artery puncture and postoperative compression hemostasis. Studies have shown that thrombectomy for cerebral artery occlusion and carotid artery stent placement can be safely performed through the brachial artery. However, current studies are based on single-center small sample studies, and there is still a lack of large-sample randomized controlled trials to verify the safety and effectiveness of neurointervention via the brachial artery.
This study intends to conduct a multicenter, prospective, and randomized study to compare the clinical results of carotid artery stent placement via the brachial and femoral artery access.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Jiangsu
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Nanjing, Jiangsu, Porcelana, 210000
- The First Affiliated Hospital of Nanjing Medical University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical diagnosis of stenosis at the origin of the carotid artery with indications for neuro-interventional treatment (symptomatic stenosis >50%; asymptomatic stenosis >70%)
- Aged 18 or above
- With palpable brachial and femoral arteries
- The patient or his/her agent understands the purpose and needs of this study and signs the informed consent
Exclusion Criteria:
- Symptomatic stenosis or occlusion of multiple vessels at the same time
- Intravascular intervention for multiple vessel lesions at the same time
- Ischemic stroke within the past 2 weeks
- Any active bleeding, severe anaemia, or coagulation disorder. At least one of the following laboratory tests must be met: haemoglobin < 10g/dL, or platelet count < 100,000 /μ L, or unadjusted INR >1.5, or PT exceeds the upper limit of normal by 1 minute or heparin-induced thrombocytopenia
- A large-area cerebral infarction stroke on the same side with sequelae may affect the judgment of the study endpoint
- A history of cerebral hemorrhage in the past six months
- Any condition that may interfere with digital subtraction angiography (DSA) or cause unsafe percutaneous arterial access Participating in other clinical trials, in the research stage or follow-up stage
- Contraindications to cerebral angiography, such as allergy to iodine contrast agents and renal insufficiency
- Unable to understand or sign the informed consent form
- Severe functional damage to important organs, assessed by clinical physicians to have high surgical risks and intolerant of interventional surgery
- Baseline modified Rankin scale greater than or equal to 2
- Expected survival is less than 6 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: the brachial group
Patients with carotid artery stenosis will be randomly selected for carotid artery stenting via the brachial artery access. |
CAS involves inserting a catheter or tube into an artery in the brachial or the femoral, and then threading the catheter through the arteries of the body to the location of the stenosis within the carotid artery in the neck. A stent is then placed in the stenosis and holds the artery open. |
|
Comparador activo: the femoral group
Patients with carotid artery stenosis will be randomly selected for carotid artery stenting via the femoral artery access. |
CAS involves inserting a catheter or tube into an artery in the brachial or the femoral, and then threading the catheter through the arteries of the body to the location of the stenosis within the carotid artery in the neck. A stent is then placed in the stenosis and holds the artery open. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Successful rate of CAS
Periodo de tiempo: 24 hours
|
Successful carotid artery stenting (CAS) is defined as access devices can be established, interventional devices can reach the lesion site, operations such as distal brain protection device release, balloon expansion and stent implantation, withdrawal protection device can be completed successfully, and residual stenosis < 30%. |
24 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Procedure time
Periodo de tiempo: 24 hours
|
time from first arterial puncture to last angiography |
24 hours
|
|
Serious adverse events (SAE)
Periodo de tiempo: 90 days
|
SAEs related to operation and device are defined as those related to operation procedure and device determined by investigators. Includes the incidence of death, new-onset stroke, or severe haemorrhage events within 90 days post-procedure, et al. |
90 days
|
|
Access puncture complications
Periodo de tiempo: 90 days
|
Hematoma at access puncture site, pseudoaneurysm, arteriovenous fistula, symptomatic severe stenosis/occlusion |
90 days
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
X-ray exposure
Periodo de tiempo: 24 hours
|
X-ray exposure is defined as the duration and equivalent of X-ray exposure recorded by the DSA machine during operation. |
24 hours
|
|
Access conversion
Periodo de tiempo: 24 hours
|
If the randomized access was not successfully completed, switched to other access |
24 hours
|
|
Degree of patient-reported comfort
Periodo de tiempo: 24 hours
|
The comfort scale adopts the simplified General Comfort Questionnaire (GCQ）developed by nursing expert Kolcaba. The scale is scored by level 1 to 4 Likert scale, with a score range of 28-112 points. The lowest score is 28 points and the highest score is 112 points. The higher the score, the higher the comfort. A total score of < 60 is low comfort, a total score of 60-90 is moderate comfort, and a total score of > 90 is high comfort. |
24 hours
|
Colaboradores e Investigadores
Investigadores
- Investigador principal: Sheng Liu, Professor, The First Affiliated Hospital with Nanjing Medical University
Publicaciones y enlaces útiles
Publicaciones Generales
- Sousa-Uva M, Neumann FJ, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur J Cardiothorac Surg. 2019 Jan 1;55(1):4-90. doi: 10.1093/ejcts/ezy289. No abstract available.
- Kendrick DB, Strout TD. The minimum clinically significant difference in patient-assigned numeric scores for pain. Am J Emerg Med. 2005 Nov;23(7):828-32. doi: 10.1016/j.ajem.2005.07.009.
- Kenawy AE, Tekle W, Hassan AE. Improved Fluoroscopy and Time Efficiency with Radial Access for Diagnostic Cerebral Angiography. J Neuroimaging. 2021 Jan;31(1):67-70. doi: 10.1111/jon.12807. Epub 2020 Nov 16.
- Stone JG, Zussman BM, Tonetti DA, Brown M, Desai SM, Gross BA, Jadhav A, Jovin TG, Jankowitz B. Transradial versus transfemoral approaches for diagnostic cerebral angiography: a prospective, single-center, non-inferiority comparative effectiveness study. J Neurointerv Surg. 2020 Oct;12(10):993-998. doi: 10.1136/neurintsurg-2019-015642. Epub 2020 Jan 22.
- Haussen DC, Nogueira RG, DeSousa KG, Pafford RN, Janjua N, Ramdas KN, Peterson EC, Elhammady MS, Yavagal DR. Transradial access in acute ischemic stroke intervention. J Neurointerv Surg. 2016 Mar;8(3):247-50. doi: 10.1136/neurintsurg-2014-011519. Epub 2015 Jan 5.
- Montorsi P, Galli S, Ravagnani MP, Teruzzi G, Calligaris G, Gili S, Caputi L, Troiano S, Del Maso R, Trabattoni D. Transradial/brachial carotid artery stenting with proximal protection: technical instructions, acute results and long-term outcomes. Minerva Cardiol Angiol. 2022 Dec;70(6):765-777. doi: 10.23736/S2724-5683.22.06223-8. Epub 2022 Dec 15.
- Lu CJ, Lin YH, Chu HJ, Tang SC, Lee CW. Safety and efficacy of the transbrachial approach for endovascular thrombectomy in patients with acute large vessel occlusion stroke. J Formos Med Assoc. 2021 Jan;120(1 Pt 3):705-712. doi: 10.1016/j.jfma.2020.08.002. Epub 2020 Aug 17.
- Starke RM, Snelling B, Al-Mufti F, Gandhi CD, Lee SK, Dabus G, Fraser JF; Society of NeuroInterventional Surgery. Transarterial and transvenous access for neurointerventional surgery: report of the SNIS Standards and Guidelines Committee. J Neurointerv Surg. 2020 Aug;12(8):733-741. doi: 10.1136/neurintsurg-2019-015573. Epub 2019 Dec 9.
- Naylor R, Rantner B, Ancetti S, de Borst GJ, De Carlo M, Halliday A, Kakkos SK, Markus HS, McCabe DJH, Sillesen H, van den Berg JC, Vega de Ceniga M, Venermo MA, Vermassen FEG, Esvs Guidelines Committee, Antoniou GA, Bastos Goncalves F, Bjorck M, Chakfe N, Coscas R, Dias NV, Dick F, Hinchliffe RJ, Kolh P, Koncar IB, Lindholt JS, Mees BME, Resch TA, Trimarchi S, Tulamo R, Twine CP, Wanhainen A, Document Reviewers, Bellmunt-Montoya S, Bulbulia R, Darling RC 3rd, Eckstein HH, Giannoukas A, Koelemay MJW, Lindstrom D, Schermerhorn M, Stone DH. Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease. Eur J Vasc Endovasc Surg. 2023 Jan;65(1):7-111. doi: 10.1016/j.ejvs.2022.04.011. Epub 2022 May 20. No abstract available.
- Heck D, Jost A, Howard G. Stenting the carotid artery from radial access using a Simmons guide catheter. J Neurointerv Surg. 2022 Feb;14(2):169-173. doi: 10.1136/neurintsurg-2020-017143. Epub 2021 Feb 25.
- Jaroenngarmsamer T, Bhatia KD, Kortman H, Orru E, Krings T. Procedural success with radial access for carotid artery stenting: systematic review and meta-analysis. J Neurointerv Surg. 2020 Jan;12(1):87-93. doi: 10.1136/neurintsurg-2019-014994. Epub 2019 Jun 14.
- Dossani RH, Waqas M, Monteiro A, Cappuzzo JM, Almayman F, Snyder KV, Levy EI, Siddiqui AH, Davies JM. Use of a sheathless 8-French balloon guide catheter (Walrus) through the radial artery for mechanical thrombectomy: technique and case series. J Neurointerv Surg. 2022 May;14(5):neurintsurg-2021-017868. doi: 10.1136/neurintsurg-2021-017868. Epub 2021 Aug 24.
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Enfermedades arteriales oclusivas
- Carrera
- Enfermedades de la arteria carótida
- Accidente cerebrovascular isquémico
- Estenosis carotídea
Otros números de identificación del estudio
- 2024-SR-534
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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