Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Drug-Coated Balloon vs Aggressive Medical Management for High-Risk Symptomatic Intracranial Atherosclerotic Stenosis (DRBEYOND2)

20 de setembro de 2026 atualizado por: Dapeng Mo, Beijing Tiantan Hospital

Drug-coated Balloon for Endovascular Treatment Versus Aggressive Medical Management in High-Risk Symptomatic Intracranial Atherosclerotic Stenosis

DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label, blinded-endpoint, parallel-group clinical trial designed to evaluate the efficacy and safety of drug-coated balloon (DCB) angioplasty plus aggressive medical management compared with aggressive medical management alone in patients with high-risk symptomatic intracranial atherosclerotic stenosis (sICAS).

A total of 570 eligible patients will be randomized in a 1:1 ratio to the DCB group or the medical management group. Patients assigned to the DCB group will undergo DCB angioplasty in addition to aggressive medical management, with rescue stenting permitted when clinically necessary according to the study protocol. Patients assigned to the control group will receive aggressive medical management alone.

The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Participants will be followed for up to 3 years to further evaluate recurrent ischemic events, vascular outcomes, functional outcomes, and long-term safety.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Estenose aterosclerótica intracraniana sintomática

Intervenção / Tratamento

Descrição detalhada

Symptomatic intracranial atherosclerotic stenosis (sICAS) is an important cause of ischemic stroke and recurrent cerebrovascular events. Although aggressive medical management is the standard treatment, patients with severe stenosis and high-risk clinical or hemodynamic features may remain at substantial risk of recurrent ischemic events. Previous randomized trials of intracranial stenting have raised concerns regarding periprocedural safety, whereas balloon angioplasty has shown potential benefit but may be limited by arterial dissection, elastic recoil, and restenosis. Drug-coated balloon angioplasty may provide an alternative endovascular strategy by combining luminal enlargement with local delivery of an antiproliferative agent while minimizing permanent intracranial implants.

DR.BEYOND-2 is an investigator-initiated, prospective, multicenter, randomized, open-label trial with blinded endpoint assessment. The study will enroll 570 patients with high-risk symptomatic intracranial atherosclerotic stenosis involving a major intracranial artery. Eligible patients must have had a recent ischemic stroke or transient ischemic attack attributable to the qualifying artery, severe intracranial stenosis, and prior treatment with at least one antithrombotic agent and/or guideline-based vascular risk-factor management. For anterior-circulation lesions, evidence of hemodynamic compromise is additionally required according to the protocol.

Participants will be randomly assigned in a 1:1 ratio to DCB angioplasty plus aggressive medical management or aggressive medical management alone. In the intervention group, DCB angioplasty will be performed using a submaximal angioplasty strategy. Rescue stenting may be used in cases of severe dissection, significant residual stenosis, or marked elastic recoil according to predefined procedural criteria.

Both treatment groups will receive standardized aggressive medical management, including antiplatelet therapy, lipid-lowering therapy, blood-pressure control, diabetes management, and management of other vascular risk factors. The medical regimen and risk-factor targets will be applied consistently across both treatment groups.

The primary endpoint is the composite of any stroke or death within 30 days after enrollment and ischemic stroke in the territory of the qualifying artery from day 31 through 1 year. Secondary outcomes include recurrent ischemic stroke or transient ischemic attack, target-vessel revascularization, hemorrhagic events, mortality, functional outcome, quality of life, and target-vessel restenosis. Exploratory outcomes include high-resolution magnetic resonance imaging changes of the target vessel and clinical and vascular outcomes through 3 years.

Participants will undergo scheduled follow-up at 7 days, 30 days, 3 months, 6 months, and 12 months, followed by assessments every 6 months through 3 years. The trial is designed to determine whether DCB-based endovascular treatment in addition to aggressive medical management can reduce recurrent cerebrovascular events while maintaining acceptable procedural safety in patients with high-risk sICAS.

Tipo de estudo

Intervencional

Inscrição (Estimado)

570

Estágio

Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Nome: Dapeng Mo, MD
Número de telefone: 18811039300
E-mail: bjttmodp@163.com

Estude backup de contato

Nome: Changchun Jiang, MD
Número de telefone: 13347180510
E-mail: 15848246828@163.com

Locais de estudo

China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100010
    - Beijing Tiantan Hospital
- Inner Mongolia
  - Baotou, Inner Mongolia, China, 014000
    - Baotou Central Hospital
    - Contato:
      
      Changchun Jiang, MD
      
      Número de telefone: +8613347180510
      
      E-mail: 15848246828@163.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

Age 18-80 years old, regardless of gender
Patients with symptomatic ICAS caused by stenosis of a major intracranial artery (the degree of ischemic stroke with target vessel stenosis within 90 days before enrollment is required to be 70-99%, or the degree of transient ischemic attack with target vessel stenosis is required to be 80-99%), standardized drug management of at least one antithrombotic drug and/or vascular risk factors
DSA or CTA confirmed that the stenosis degree of one main intracranial artery (internal carotid artery C4-C7 segment, middle cerebral artery M1 segment, vertebral artery V4 segment and basilar artery) was between 70% and 99% (measured by WASID method), and was corresponding to the clinical symptoms. The normal diameter of the proximal end of the target lesion was ≥ 2mm, and the length of the target lesion was ≤ 15mm
If the target lesion is located in the anterior circulation system (C4-C7 of the internal carotid artery or M1 of the middle cerebral artery), it is required that there is hypoperfusion in the blood supply area of the target vessel (at least one of the following conditions is met): ①head CTP or PWI showed that CBF in the target vessel area decreased significantly (the lesion side decreased by more than 30% compared with the opposite side); ②Cerebral infarction with hemodynamic abnormalities confirmed by head CT or MRI (such as watershed infarction); ③ASITN/SIR collateral circulation score based on DSA<3 points)
Those who voluntarily participated in the study and signed the informed consent

Exclusion Criteria:

Serious calcification of target vessels, or serious distortion of target vessels or anatomical factors make it difficult for interventional instruments to be in place
Severe stenosis or occlusion of extracranial or intracranial vessels in series at the proximal or distal end of the target vessel
Major surgical operations have been performed in recent 3 weeks
Cerebral hemorrhage, massive cerebral infarction (the infarct area is greater than 50% of the middle cerebral artery supply area; cerebellar infarction: the infarct diameter is greater than 3cm) and myocardial infarction have occurred in the past three months
The target lesion has undergone stent implantation before
Intracranial artery stenosis caused by non atherosclerotic lesions, including but not limited to: arterial dissection, moyamoya disease, vasculitis, radiation vascular disease or fibromuscular dysplasia
mRS score ≥ 3
Patients with coagulation dysfunction
Those who cannot tolerate anesthesia and anticoagulant drugs, are contraindicated or allergic to surgical drugs (paclitaxel, heparin, contrast agent, aspirin, clopidogrel, etc.), and are allergic to surgical instruments or operating devices
Platelet (PLT<90×109/L),hematocrit (<30%), international normalized ratio (INR)>1.5, uncontrollable severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg),severe liver injury (ALT or AST more than 3 times the normal value), severe renal function injury (creatinine>3mg/dl,>265μmol/L),and severe insufficiency of other important organs such as heart and lung
The subjects participated in other clinical trials and have not completed the follow-up or the researchers judged that the patients' compliance was poor and they were unable to complete the follow-up as required
Pregnant or lactating women, or those who plan to become pregnant within one year
The disease will cause difficulties in treatment and follow-up evaluation (such as dementia or mental disorders, cancer, infection, severe metabolic diseases), and it is speculated that the life expectancy of the participants is less than 3 years
Other cases that clinicians think should be excluded

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Tratamento
Alocação: Randomizado
Modelo Intervencional: Atribuição Paralela
Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço Grupo de Participantes / Braço Um grupo ou subgrupo de participantes em um estudo clínico que recebe uma intervenção/tratamento específico, ou nenhuma intervenção, de acordo com o protocolo do estudo.	Intervenção / Tratamento Intervenção / Tratamento Um processo ou ação que é o foco de um estudo clínico. As intervenções incluem medicamentos, dispositivos médicos, procedimentos, vacinas e outros produtos em fase de investigação ou já disponíveis. As intervenções também podem incluir abordagens não invasivas, como educação ou modificação da dieta e exercícios.
Experimental: Drug-Coated Balloon Angioplasty Plus Aggressive Medical Management Participants assigned to this group will undergo drug-coated balloon angioplasty in addition to aggressive medical management. Rescue stenting is permitted when clinically necessary according to predefined procedural criteria, including severe dissection, significant residual stenosis, or marked elastic recoil.	Procedimento: Drug-Coated Balloon Angioplasty Participants randomized to the experimental group will undergo intracranial drug-coated balloon angioplasty using a submaximal angioplasty strategy. Predilation with an uncoated balloon is performed before drug-coated balloon angioplasty. Rescue stenting is permitted when severe dissection, residual stenosis >50%, marked elastic recoil, or other protocol-defined conditions occur.
Comparador Ativo: Aggressive Medical Management Alone Participants assigned to this group will receive aggressive medical management alone, including standardized antiplatelet therapy and intensive management of vascular risk factors.	Outro: Aggressive Medical Management Aggressive medical management will be provided to participants in both groups and includes antiplatelet therapy, intensive lipid-lowering treatment, blood pressure and glucose control, and management of other vascular risk factors. Aspirin 100 mg/day is administered throughout follow-up, with clopidogrel 75 mg/day during the first 90 days after enrollment. Alternative antiplatelet therapy may be used according to platelet function or CYP2C19 genotype when appropriate.

Grupo de Participantes / Braço

Intervenção / Tratamento

Experimental: Drug-Coated Balloon Angioplasty Plus Aggressive Medical Management

Participants assigned to this group will undergo drug-coated balloon angioplasty in addition to aggressive medical management. Rescue stenting is permitted when clinically necessary according to predefined procedural criteria, including severe dissection, significant residual stenosis, or marked elastic recoil.

Procedimento: Drug-Coated Balloon Angioplasty

Participants randomized to the experimental group will undergo intracranial drug-coated balloon angioplasty using a submaximal angioplasty strategy. Predilation with an uncoated balloon is performed before drug-coated balloon angioplasty. Rescue stenting is permitted when severe dissection, residual stenosis >50%, marked elastic recoil, or other protocol-defined conditions occur.

Comparador Ativo: Aggressive Medical Management Alone

Participants assigned to this group will receive aggressive medical management alone, including standardized antiplatelet therapy and intensive management of vascular risk factors.

Outro: Aggressive Medical Management

Aggressive medical management will be provided to participants in both groups and includes antiplatelet therapy, intensive lipid-lowering treatment, blood pressure and glucose control, and management of other vascular risk factors. Aspirin 100 mg/day is administered throughout follow-up, with clopidogrel 75 mg/day during the first 90 days after enrollment. Alternative antiplatelet therapy may be used according to platelet function or CYP2C19 genotype when appropriate.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado	Descrição da medida	Prazo
Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment Prazo: within 30 days after enrollment;within 30 days to 1 year after enrollment	Percentage of Participants With Any stroke or death within 30 days after enrollment and recurrence of ischemic stroke in the target vessel area within 30 days to 1 year after enrollment.	within 30 days after enrollment;within 30 days to 1 year after enrollment

Medidas de resultados secundários

Outras medidas de resultado

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Beijing Tiantan Hospital

Colaboradores

Baotou Central Hospital

Investigadores

Investigador principal: Changchun Jiang, MD, Baotou Central Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2028

Conclusão do estudo (Estimado)

1 de junho de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

15 de setembro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de setembro de 2026

Primeira postagem (Real)

21 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

HX-A-2026071-001

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Medida de resultado	Descrição da medida	Prazo
Percentage of Participants With Any stroke or death within 30 days after enrollment Prazo: Within 30 days after enrollment	Percentage of Participants With Any stroke or death within 30 days after enrollment.	Within 30 days after enrollment
Percentage of Participants With Recurrent Ischemic Stroke in any region within 30 days to 1 year after enrollment Prazo: Within 30 days to 1 year after enrollment	Recurrence of ischemic stroke in any region within 30 days to 1 year after enrollment.	Within 30 days to 1 year after enrollment
Percentage of Participants With Recurrent TIA in the Territory of the Qualifying Artery Within 1 Year After Enrollment Prazo: Within 1 year after enrollment	TIA recurrence in target vessel area within 1 year after enrollment.	Within 1 year after enrollment
Percentage of Participants With Recurrent TIA in Any Vascular Territory Within 1 Year After Enrollment Prazo: Within 1 year after enrollment	TIA recurrence in any region within 1 year after enrollment.	Within 1 year after enrollment
Percentage of Participants Undergoing Target-Vessel Revascularization Within 1 Year After Enrollment Prazo: Within 1 year after enrollment	Salvage revascularization of target vessels within 1 year after enrollment (mechanical thrombectomy/arterial thrombolysis/angioplasty/vascular bypass).	Within 1 year after enrollment
Percentage of Participants With Coronary Ischemic Events Within 1 Year After Enrollment Prazo: Within 1 year after enrollment	Coronary ischemic events within 1 year after enrollment (including myocardial infarction or angina pectoris).	Within 1 year after enrollment
Modified Rankin Scale (mRS) Score at 1 Year (±1 Month) After Enrollment Prazo: 1 year (± 1 month) after enrollment	The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.	1 year (± 1 month) after enrollment
EQ-5D Score at 1 Year (±1 Month) After Enrollment Prazo: 1 year (± 1 month) after enrollment	The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) at 1 year (± 1 month) after enrollment.	1 year (± 1 month) after enrollment
Percentage of Participants With Target-Vessel Restenosis at 1 Year (±1 Month) After Enrollment in the Experimental Group Prazo: 1 year (±1 month) after enrollment	Target vessel restenosis at 1 year (±1 month) after enrollment (experimental group only, evaluated by CTA).	1 year (±1 month) after enrollment
Percentage of Participants With Symptomatic Target-Vessel Restenosis at 1 Year (±1 Month) After Enrollment in the Experimental Group Prazo: 1 year (±1 month) after enrollment	Symptomatic restenosis of target vessels at 1 year (± 1 month) after enrollment (evaluation of the experimental group only).	1 year (±1 month) after enrollment
Percentage of Participants With Hemorrhagic Stroke Within 1 Year After Enrollment Prazo: Within 1 year after enrollment	Hemorrhagic stroke within 1 year after enrollment (cerebral hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc.).	Within 1 year after enrollment
Percentage of Participants With Extracranial Hemorrhage Within 1 Year After Enrollment Prazo: Within 1 year after enrollment	Extracranial hemorrhage within 1 year after enrollment (gastrointestinal bleeding, hematuria, epistaxis or fundus hemorrhage, etc.).	Within 1 year after enrollment
Percentage of Participants With All-Cause Mortality Within 1 Year After Enrollment Prazo: Within 1 year after enrollment	All cause death within 1 year after enrollment.	Within 1 year after enrollment
Percentage of Participants With Stroke-Related Mortality Within 1 Year After Enrollment Prazo: Within 1 year after enrollment	Stroke related death within 1 year after enrollment.	Within 1 year after enrollment
Percentage of Participants With Other Serious Adverse Events Within 1 Year After Enrollment Prazo: Within 1 year after enrollment	Other serious adverse events within 1 year after enrollment.	Within 1 year after enrollment

Medida de resultado	Descrição da medida	Prazo
Changes in Target-Vessel Imaging Characteristics Assessed by High-Resolution MRI at 1 Year (±1 Month) After Enrollment Prazo: 1 year (± 1 month) after enrollment	High-resolution MRI will be used to characterize interval changes in the vessel wall and atherosclerotic plaque of the qualifying artery, including plaque enhancement and other morphological characteristics, as applicable.	1 year (± 1 month) after enrollment
Percentage of Participants With Recurrent Ischemic Stroke in Any Vascular Territory Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	Recurrence of ischemic stroke in any region within 3 years after enrollment.	Within 3 years after enrollment
Percentage of Participants With Recurrent Ischemic Stroke in the Territory of the Qualifying Artery Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	Recurrence of ischemic stroke in target vessel area within 3 years after enrollment.	Within 3 years after enrollment
Percentage of Participants With Recurrent TIA in the Territory of the Qualifying Artery Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	TIA recurrence in target vessel area within 3 years after enrollment.	Within 3 years after enrollment
Percentage of Participants With Recurrent TIA in Any Vascular Territory Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	TIA recurrence in any region within 3 years after enrollment.	Within 3 years after enrollment
Percentage of Participants Undergoing Target-Vessel Revascularization Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	Salvage revascularization of target vessels within 3 years after enrollment (mechanical thrombectomy/arterial thrombolysis/angioplasty/vascular bypass).	Within 3 years after enrollment
Percentage of Participants With Coronary Ischemic Events Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	Coronary ischemic events within 3 years after enrollment (including myocardial infarction or angina pectoris).	Within 3 years after enrollment
Modified Rankin Scale (mRS) Score at 3 Years After Enrollment Prazo: 3 years after enrollment	The modified Rankin scale (mRS) ranged from 0 to 6, with a score of 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but remaining able to walk unassisted, 4 moderately severe disability,5 severe disability, and 6 death.	3 years after enrollment
Q-5D Score at 3 Years After Enrollment Prazo: 3 years after enrollment	The change in functional health status and quality of life measured by EuroQol five dimensions questionnaire (EQ-5D) at 3 years after enrollment.	3 years after enrollment
Target vessel restenosis at 3 years after enrollment (only the experimental group, evaluated by CTA) Prazo: 3 years after enrollment	Target vessel restenosis at 3 years after enrollment (only the experimental group, evaluated by CTA).	3 years after enrollment
Percentage of Participants With Target-Vessel Restenosis at 3 Years After Enrollment in the Experimental Group Prazo: 3 years after enrollment	Symptomatic restenosis of target vessels at 3 years after enrollment (evaluation only in the experimental group).	3 years after enrollment
Percentage of Participants With Hemorrhagic Stroke Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	Hemorrhagic stroke within 3 years after enrollment (cerebral hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc.).	Within 3 years after enrollment
Percentage of Participants With Extracranial Hemorrhage Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	Extracranial hemorrhage within 3 years after enrollment (gastrointestinal bleeding, hematuria, epistaxis or fundus hemorrhage, etc.).	Within 3 years after enrollment
Percentage of Participants With All-Cause Mortality Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	All cause death within 3 years after enrollment.	Within 3 years after enrollment
Percentage of Participants With Stroke-Related Mortality Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	Stroke related death within 3 years after enrollment.	Within 3 years after enrollment
Percentage of Participants With Other Serious Adverse Events Within 3 Years After Enrollment Prazo: Within 3 years after enrollment	Other serious adverse events within 3 years after enrollment.	Within 3 years after enrollment

Drug-Coated Balloon vs Aggressive Medical Management for High-Risk Symptomatic Intracranial Atherosclerotic Stenosis (DRBEYOND2)

Drug-coated Balloon for Endovascular Treatment Versus Aggressive Medical Management in High-Risk Symptomatic Intracranial Atherosclerotic Stenosis

Visão geral do estudo

Status

Condições

Intervenção / Tratamento

Descrição detalhada

Tipo de estudo

Inscrição (Estimado)

Estágio

Contactos e Locais

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Critérios de elegibilidade

Idades elegíveis para estudo

Aceita Voluntários Saudáveis

Gêneros Elegíveis para o Estudo

Descrição

Plano de estudo

Como o estudo é projetado?

Detalhes do projeto

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço

Intervenção / Tratamento

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado

Descrição da medida

Prazo

Medidas de resultados secundários

Medida de resultado

Descrição da medida

Prazo

Outras medidas de resultado

Medida de resultado

Descrição da medida

Prazo

Colaboradores e Investigadores

Patrocinador

Colaboradores

Investigadores

Datas de registro do estudo

Datas Principais do Estudo

Início do estudo (Estimado)

Conclusão Primária (Estimado)

Conclusão do estudo (Estimado)

Datas de inscrição no estudo

Enviado pela primeira vez

Enviado pela primeira vez que atendeu aos critérios de CQ

Primeira postagem (Real)

Atualizações de registro de estudo

Última Atualização Postada (Real)

Última atualização enviada que atendeu aos critérios de controle de qualidade

Última verificação

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Estuda um produto de dispositivo regulamentado pela FDA dos EUA