Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms (FD-SAC BAS)
4 de agosto de 2026 actualizado por: Feng wen feng, Nanfang Hospital, Southern Medical University
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study
This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms.
A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice.
The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure.
The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
Intracranial bifurcation aneurysms are common and are challenging to treat because of their complex anatomy. Flow diverters have emerged as an innovative endovascular therapy and have shown preliminary efficacy in bifurcation aneurysms. However, compared with conventional stent-assisted coiling, real-world evidence regarding early postoperative complication risks and related influencing factors remains limited.
This study will establish a prospective multicenter real-world database to compare the incidence of early complications after treatment with a flow diverter versus stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. Eligible patients who provide informed consent and meet the inclusion and exclusion criteria will be enrolled from three centers in China. Patients treated with a flow diverter will enter the flow diverter group, and patients treated with stent-assisted coiling will enter the stent-assisted coiling group.
All patients will undergo preoperative evaluation, perioperative management, postoperative antiplatelet therapy, and follow-up according to clinical practice and relevant guidelines. Data collected will include demographic characteristics, medical history, physical examination, laboratory tests, imaging findings, aneurysm morphology, procedural details, device information, medication history, and adverse events. Follow-up will be performed at 30 days after treatment to assess safety outcomes.
Tipo de estudio
De observación
Inscripción (Estimado)
274
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Huibin Kang Study Contact, MD
- Número de teléfono: 13520296286
- Correo electrónico: kanghuibindoctor@163.com
Ubicaciones de estudio
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Guangzhou, Porcelana
- Reclutamiento
- Zhujiang Hospital, Southern Medical University
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Contacto:
- Xin Feng, Principal Investigator
- Correo electrónico: 11111111@163.com
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Guangzhou, Porcelana
- Reclutamiento
- Guangdong Province People's Hospital
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Contacto:
- Shengpan Chen, MD
- Correo electrónico: 19801168712@163.com
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Guangdong
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Guangzhou, Guangdong, Porcelana
- Reclutamiento
- Nanfang Hospital, Southern Medical University
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Contacto:
- Wenfeng Feng Feng, Principal Investigator, MD
- Número de teléfono: 13501509911
- Correo electrónico: fengwf1967@163.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
Patients aged 18 to 75 years with unruptured, saccular, wide-neck intracranial bifurcation aneurysms diagnosed by CTA, MRA, or DSA who meet the clinical indications for endovascular treatment and are treated at participating centers.
Eligible patients must provide written informed consent and will receive either flow diverter treatment or stent-assisted coiling according to the study protocol.
Descripción
Inclusion Criteria:
- Voluntarily provides written informed consent.
- Aged 18 to 75 years.
- Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm.
- Able to understand the purpose of the study.
Exclusion Criteria:
- Patients with two or more multiple aneurysms, all of which require treatment within 1 year.
- Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.
- Patients with ruptured aneurysms or narrow-neck aneurysms.
- Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month.
- Patients with poor clinical condition, defined as modified Rankin Scale score ≥3.
- Patients who have already planned to undergo surgical or interventional treatment within 3 months.
- Patients considered by the investigator to be unsuitable for endovascular treatment, such as those with no suitable vascular access, excessively tortuous vessels, or difficulty in stent delivery.
- Patients unsuitable for anesthesia or endovascular treatment, including those with major heart, lung, liver, spleen, or kidney disease, brain tumor, severe active infection, disseminated intravascular coagulation, or a history of severe psychiatric disorder.
- Patients unable to receive antiplatelet or anticoagulant therapy.
- Patients with a previous or possible severe reaction to contrast agents that would prevent completion of pre-treatment medication or treatment.
- Patients with a known history of allergy to cobalt-chromium or nickel-titanium alloy materials.
- Patients who participated in another drug or medical device clinical trial before enrollment and have not reached the time point of the primary endpoint.
- Pregnant or lactating women.
- Patients with life expectancy less than 12 months.
- Patients judged by the investigator to have poor compliance and inability to complete the study as required
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Flow Diverter Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive flow diverter treatment in routine clinical practice.
|
Flow diverter treatment will be performed according to routine clinical practice and relevant guidelines.
A flow-diverting stent will be deployed to cover the aneurysm neck after angiographic evaluation and device sizing.
Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.
|
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Stent-Assisted Coiling Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive stent-assisted coiling in routine clinical practice.
|
Stent-assisted coiling will be performed according to routine clinical practice and relevant guidelines.
A stent will be deployed across the aneurysm neck, followed by coil embolization of the aneurysm.
Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite incidence of any stroke or all-cause death within 30 days after procedure
Periodo de tiempo: Within 30 days after procedure
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The primary outcome is the occurrence of any stroke or all-cause death within 30 days after the endovascular procedure.
Stroke is defined as an acute onset of focal or global neurological dysfunction caused by vascular injury of the brain, spinal cord, or retina due to hemorrhage or infarction, with symptoms lasting 24 hours or longer.
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Within 30 days after procedure
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of any stroke within 30 days after procedure
Periodo de tiempo: Within 30 days after procedure
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Incidence of any ischemic or hemorrhagic stroke within 30 days after the procedure.
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Within 30 days after procedure
|
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Incidence of transient ischemic attack within 30 days after procedure
Periodo de tiempo: Within 30 days after procedure
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Incidence of transient ischemic attack within 30 days after the procedure.
Transient ischemic attack is defined as a transient episode of focal neurological dysfunction caused by ischemia of the brain, spinal cord, or retina, with symptoms lasting less than 24 hours and without acute infarction.
|
Within 30 days after procedure
|
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Incidence of all-cause death within 30 days after procedure
Periodo de tiempo: Within 30 days after procedure
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Incidence of death from any cause within 30 days after the procedure.
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Within 30 days after procedure
|
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Incidence of adverse events and serious adverse events within 30 days after procedure
Periodo de tiempo: Within 30 days after procedure
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Incidence of adverse events and serious adverse events recorded during the perioperative period and follow-up period.
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Within 30 days after procedure
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Wenfeng Feng, MD, Nanfang Hospital, Southern Medical University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.
- Brinjikji W, Murad MH, Lanzino G, Cloft HJ, Kallmes DF. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013 Feb;44(2):442-7. doi: 10.1161/STROKEAHA.112.678151. Epub 2013 Jan 15.
- Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
- Luo B, Kang H, Zhang H, Li T, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X. Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion. Ther Adv Neurol Disord. 2020 Nov 2;13:1756286420967828. doi: 10.1177/1756286420967828. eCollection 2020.
- Cagnazzo F, Limbucci N, Nappini S, Renieri L, Rosi A, Laiso A, Tiziano di Carlo D, Perrini P, Mangiafico S. Y-Stent-Assisted Coiling of Wide-Neck Bifurcation Intracranial Aneurysms: A Meta-Analysis. AJNR Am J Neuroradiol. 2019 Jan;40(1):122-128. doi: 10.3174/ajnr.A5900. Epub 2018 Dec 6.
- Kashkoush A, El-Abtah ME, Petitt JC, Glauser G, Winkelman R, Achey RL, Davison M, Abdulrazzak MA, Hussain SM, Toth G, Bain M, Moore N. Flow diversion for the treatment of intracranial bifurcation aneurysms: a systematic review and meta-analysis. J Neurointerv Surg. 2024 Aug 14;16(9):921-927. doi: 10.1136/jnis-2023-020582.
- Rouchaud A, Brinjikji W, Lanzino G, Cloft HJ, Kadirvel R, Kallmes DF. Delayed hemorrhagic complications after flow diversion for intracranial aneurysms: a literature overview. Neuroradiology. 2016 Feb;58(2):171-7. doi: 10.1007/s00234-015-1615-4. Epub 2015 Nov 9.
- Cagnazzo F, Fanti A, Lefevre PH, Derraz I, Dargazanli C, Gascou G, Riquelme C, Ahmed R, Bonafe A, Costalat V. Distal anterior cerebral artery aneurysms treated with flow diversion: experience of a large-volume center and systematic review of the literature. J Neurointerv Surg. 2021 Jan;13(1):42-48. doi: 10.1136/neurintsurg-2020-015980. Epub 2020 May 26.
- Choi JH, Park JE, Kim MJ, Kim BS, Shin YS. Aneurysmal Neck Clipping as the Primary Treatment Option for Both Ruptured and Unruptured Middle Cerebral Artery Aneurysms. J Korean Neurosurg Soc. 2016 May;59(3):269-75. doi: 10.3340/jkns.2016.59.3.269. Epub 2016 May 10.
- Kang H, Luo B, Liu J, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Zhang Y, Yang X. Postoperative occlusion degree after flow-diverter placement with adjunctive coiling: analysis of complications. J Neurointerv Surg. 2022 Apr;14(4):371-375. doi: 10.1136/neurintsurg-2021-017445. Epub 2021 May 13.
- Cekirge HS, Saatci I. A New Aneurysm Occlusion Classification after the Impact of Flow Modification. AJNR Am J Neuroradiol. 2016 Jan;37(1):19-24. doi: 10.3174/ajnr.A4489. Epub 2015 Aug 27.
- Byoun HS, Lim JW, Han MH, Jeong EO, Koh HS, Kwon HJ. Coil embolization of the middle cerebral artery bifurcation aneurysms: Feasibility and durability. J Clin Neurosci. 2024 Aug;126:294-306. doi: 10.1016/j.jocn.2024.06.016. Epub 2024 Jul 13.
- Saleme S, Iosif C, Ponomarjova S, Mendes G, Camilleri Y, Caire F, Boncoeur MP, Mounayer C. Flow-diverting stents for intracranial bifurcation aneurysm treatment. Neurosurgery. 2014 Dec;75(6):623-31; quiz 631. doi: 10.1227/NEU.0000000000000522.
- Salem MM, Khorasanizadeh M, Lay SV, Renieri L, Kuhn AL, Sweid A, Massari F, Moore JM, Tjoumakaris SI, Jabbour P, Puri AS, Ogilvy CS, Jankowitz BT, Burkhardt JK, Kan P, Limbucci N, Cognard C, Thomas AJ. Endoluminal flow diverting stents for middle cerebral artery bifurcation aneurysms: multicenter cohort. J Neurointerv Surg. 2022 Nov;14(11):1084-1089. doi: 10.1136/neurintsurg-2021-018224. Epub 2021 Nov 3.
- Iosif C, Mounayer C, Yavuz K, Saleme S, Geyik S, Cekirge HS, Saatci I. Middle Cerebral Artery Bifurcation Aneurysms Treated by Extrasaccular Flow Diverters: Midterm Angiographic Evolution and Clinical Outcome. AJNR Am J Neuroradiol. 2017 Feb;38(2):310-316. doi: 10.3174/ajnr.A5022. Epub 2016 Dec 15.
- Limbucci N, Leone G, Renieri L, Nappini S, Cagnazzo F, Laiso A, Muto M, Mangiafico S. Expanding Indications for Flow Diverters: Distal Aneurysms, Bifurcation Aneurysms, Small Aneurysms, Previously Coiled Aneurysms and Clipped Aneurysms, and Carotid Cavernous Fistulas. Neurosurgery. 2020 Jan 1;86(Suppl 1):S85-S94. doi: 10.1093/neuros/nyz334.
- Turhon M, Kang H, Li M, Liu J, Zhang Y, Zhang Y, Huang J, Luo B, Liu J, Zhang H, Li T, Song D, Zhao Y, Guan S, Aximujiang A, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Zhang X, Gu Y, Yang X. Treatment of fusiform aneurysms with a pipeline embolization device: a multicenter cohort study. J Neurointerv Surg. 2023 Apr;15(4):315-320. doi: 10.1136/neurintsurg-2021-018539. Epub 2022 Mar 30.
- O'Kelly CJ, Spears J, Chow M, Wong J, Boulton M, Weill A, Willinsky RA, Kelly M, Marotta TR. Canadian experience with the pipeline embolization device for repair of unruptured intracranial aneurysms. AJNR Am J Neuroradiol. 2013 Feb;34(2):381-7. doi: 10.3174/ajnr.A3224. Epub 2012 Aug 2.
- Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013 Jun;267(3):858-68. doi: 10.1148/radiol.13120099. Epub 2013 Feb 15.
- Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A new endoluminal, flow-disrupting device for treatment of saccular aneurysms. Stroke. 2007 Aug;38(8):2346-52. doi: 10.1161/STROKEAHA.106.479576. Epub 2007 Jul 5.
- Gao BL, Hao H, Hao W, Ren CF, Yang L, Han Y. Cerebral aneurysms at major arterial bifurcations are associated with the arterial branch forming a smaller angle with the parent artery. Sci Rep. 2022 Mar 24;12(1):5106. doi: 10.1038/s41598-022-09000-7.
- Hetts SW. Back to the Future: A Mesh Balloon for Wide-necked Brain Aneurysm Endovascular Treatment. Radiology. 2022 Aug;304(2):383-384. doi: 10.1148/radiol.213306. Epub 2022 Apr 19. No abstract available.
- Kuwajima T, Kazekawa K, Maruyama K, Yoshida S, Hama Y, Morita H, Ota Y, Tashiro N, Hiraoka F, Kawano H, Yano S, Aikawa H, Go Y, Yoshimura S. Usefulness and problems of Y-Stent and T-Stent assisted coiling for unruptured cerebral aneurysms. J Stroke Cerebrovasc Dis. 2022 Oct;31(10):106668. doi: 10.1016/j.jstrokecerebrovasdis.2022.106668. Epub 2022 Aug 18.
- Chung J, Park W, Park JC, Kwun BD, Ahn JS. Characteristics of Peri-Internal Carotid Artery Bifurcation Aneurysms According to a New Anatomic Classification: How to Overcome Difficulties in the Microsurgical Treatment of Posteroinferiorly Projecting Carotid-A1 Junctional Aneurysms. World Neurosurg. 2019 Jun;126:e1219-e1227. doi: 10.1016/j.wneu.2019.02.232. Epub 2019 Mar 16.
- Narata AP, de Moura FS, Larrabide I, Perrault CM, Patat F, Bibi R, Velasco S, Januel AC, Cognard C, Chapot R, Bouakaz A, Sennoga CA, Marzo A. The Role of Hemodynamics in Intracranial Bifurcation Arteries after Aneurysm Treatment with Flow-Diverter Stents. AJNR Am J Neuroradiol. 2018 Feb;39(2):323-330. doi: 10.3174/ajnr.A5471. Epub 2017 Nov 23.
- Campos JK, Lien BV, Wang AS, Lin LM. Advances in endovascular aneurysm management: coiling and adjunctive devices. Stroke Vasc Neurol. 2020 Mar 15;5(1):14-21. doi: 10.1136/svn-2019-000303. eCollection 2020.
- van der Kamp LT, Rinkel GJE, Verbaan D, van den Berg R, Vandertop WP, Murayama Y, Ishibashi T, Lindgren A, Koivisto T, Teo M, St George J, Agid R, Radovanovic I, Moroi J, Igase K, van den Wijngaard IR, Rahi M, Rinne J, Kuhmonen J, Boogaarts HD, Wong GKC, Abrigo JM, Morita A, Shiokawa Y, Hackenberg KAM, Etminan N, van der Schaaf IC, Zuithoff NPA, Vergouwen MDI. Risk of Rupture After Intracranial Aneurysm Growth. JAMA Neurol. 2021 Oct 1;78(10):1228-1235. doi: 10.1001/jamaneurol.2021.2915.
- Alfano JM, Kolega J, Natarajan SK, Xiang J, Paluch RA, Levy EI, Siddiqui AH, Meng H. Intracranial aneurysms occur more frequently at bifurcation sites that typically experience higher hemodynamic stresses. Neurosurgery. 2013 Sep;73(3):497-505. doi: 10.1227/NEU.0000000000000016.
- Sharma D. Perioperative Management of Aneurysmal Subarachnoid Hemorrhage. Anesthesiology. 2020 Dec 1;133(6):1283-1305. doi: 10.1097/ALN.0000000000003558.
- Tawk RG, Hasan TF, D'Souza CE, Peel JB, Freeman WD. Diagnosis and Treatment of Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage. Mayo Clin Proc. 2021 Jul;96(7):1970-2000. doi: 10.1016/j.mayocp.2021.01.005. Epub 2021 May 13.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
19 de marzo de 2026
Finalización primaria (Estimado)
19 de marzo de 2027
Finalización del estudio (Estimado)
19 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
4 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2026
Publicado por primera vez (Actual)
10 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
4 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026STI341 (Identificador de registro: National Engineering Research Center of Science and Technology Information STI Digital Health Laboratory)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
The individual participant data sharing plan has not yet been determined and will be decided according to institutional policy, ethics committee requirements, and participant privacy considerations.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .