Safety and Efficacy Analysis of Stent-assisted Coil Embolization in the Treatment of Acute Ruptured Intracranial Aneurysms in the Perioperative Period.
28 de junho de 2026 atualizado por: Tang-Du Hospital
To determine the perioperative safety and efficacy of stent-assisted coil embolization of intracranial aneurysms in the acute phase.
Intravenous antiplatelet drugs that are clinically easy to administer, have good reproducibility and good controllability are used.The program focuses on exploring the safety of emergency stent-assisted embolization of intracranial wide carotid aneurysms, and then determines the effectiveness of treatment in preventing rebleeding and preventing aneurysm recurrence in the long term.
Visão geral do estudo
Status
Recrutamento
Descrição detalhada
Based on the current clinical research results and existing clinical needs, this paper conducts a study on how to carry out stent-assisted embolization of ruptured aneurysms in the acute stage, aiming to explore the safety and embolization effect of stent-assisted embolization aneurysms in the acute stage under the protection of intravenous antiplatelet drugs, focusing on the probability of complications and related clinical consequences in the perioperative period. Thus, it provides a reasonable, safe and effective interventional treatment plan for a large number of patients with ruptured aneurysms who need interventional treatment in clinical practice.
Study endpoints:
Main endpoints: 1. Complications related to surgical treatment; 2. New stent-related (possibly related) ischemic events and bleeding events within 30 days after surgery. 3. Perioperative-related mortality rate (death from any cause and Neurological dysfunction with NIHSS greater than 4 points due to complications)
Secondary study endpoints: 1. Degree of embolism immediately after surgery (R grade); 2. 30-day patient mRS score; 3. The degree of aneurysm embolism at 1 year after surgery; 4. New treatment-related ischemia and bleeding events 30 days to 1 year after thrombosis; 4. Proportion of restenosis within the stent at 1 year; 5 mRS score at 1 year postoperatively.
Tipo de estudo
Intervencional
Inscrição (Estimado)
174
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.
Locais de estudo
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Shaanxi
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Xi'an, Shaanxi, China, 710038
- Recrutamento
- Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038
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Contato:
- Jian Ping Deng,M.D Ph.D;+86 13991139395;13991139395@163.com Zhen Wei Zhao,M.D Ph.D
- Número de telefone: +8613991139395
- E-mail: 13991139395@163.com
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Contato:
- Tao Zhang,M.D Ph.D
- Número de telefone: +8613519150673
- E-mail: baltimore@163.com
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Subinvestigador:
- Wei Fang,M.D Ph.D Fang
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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
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Patients aged 18-80 with a single ruptured cystic aneurysm at the center, or multiple aneurysms with a clear responsible lesion, only treat the responsible lesion
- Aneurysms with a wide neck, neck ≥4mm, or neck/body ratio >1/2
- Treatment performed within 7 days of the last hemorrhage
- Patients undergoing interventional treatment using a stent, including cases of remedial stent use.5. Hunt & Hess grade 1-3
Exclusion Criteria:
- Exclude patients who meet the inclusion criteria but fail to undergo successful SAC embolization
- Exclude non-cystic aneurysms, such as dissection, pseudoaneurysm, and distal aneurysm patients
- Patients with other cerebrovascular diseases, including AVM, DAVF, Moyamoya disease, and arterial stenosis greater than 50%
- Patients unable to use intravenous antiplatelet drugs
- Patients with poor condition prior to aneurysm rupture, mRS ≥ 2
- Exclude pregnant patients
- Exclude patients with other severe preoperative diseases, such as malignant tumors or cardiopulmonary and renal diseases
- Patients with multiple aneurysms where the responsible lesion cannot be identified and treatment is done for all
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: We will perform stent-assisted embolization on patients who meet the inclusion criteria.
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1. Patients aged 18-80 with a single ruptured cystic aneurysm at the center, or multiple aneurysms with a clear responsible lesion, only treat the responsible lesion.2.
Aneurysms with a wide neck, neck ≥4mm, or neck/body ratio >1/2.3.
Treatment performed within 7 days of the last hemorrhage.4.
Patients undergoing interventional treatment using a stent, including cases of remedial stent use.5.
Hunt & Hess grade 1-3.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure
Prazo: From the procedure to 30 days post-procedure
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Stroke was defined as an acute neurological deficit lasting >24 hours or resulting in death, with corresponding neuroimaging evidence.
Events were adjudicated as stent-related by the independent clinical events committee.
Confirmation required head CT, MRI, or DSA performed from the time of procedure completion to postoperative day 30.
The number of participants experiencing such events was reported.
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From the procedure to 30 days post-procedure
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Number of participants with perioperative NIHSS score ≥4 or all-cause mortality.
Prazo: from the start of the procedure to postoperative day 30.
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Perioperative period is defined as the time from the start of the procedure to postoperative day 30.
The number of participants with a National Institutes of Health Stroke Scale (NIHSS) score of 4 or higher at any time during this period, or death from any cause during this period, was reported.
NIHSS is a 15-item neurological examination scale used to evaluate the severity of stroke, with scores ranging from 0 to 42; higher scores indicate greater severity.
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from the start of the procedure to postoperative day 30.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Degree of immediate post-operative aneurysm occlusion
Prazo: Immediately post-procedure
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Immediate post-embolization angiography was performed to assess the degree of aneurysm occlusion using the Raymond grading system.
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Immediately post-procedure
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30-day post-procedure mRS score
Prazo: From immediately post-procedure to post-operative day 30
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From immediately post-procedure to post-operative day 30
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Degree of aneurysm occlusion at 1 year post-operation
Prazo: From the post-operative period up to 1 year post-procedure
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All patients underwent repeat pan-cerebral DSA at 1 year post-operation; angiographic findings were classified as no recurrence, mild recurrence, or significant recurrence.
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From the post-operative period up to 1 year post-procedure
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Treatment-related ischemic or hemorrhagic events occurring between 1 month and 1 year post-procedure
Prazo: From 1 month to 1 year post-procedure
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Any ischemic or hemorrhagic neurological dysfunction occurring between 1 month and 1 year post-procedure, confirmed by cranial CT or MRI and adjudicated as definitely procedure-related.
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From 1 month to 1 year post-procedure
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Proportion of in-stent restenosis at 1 year post-procedure
Prazo: At 1 year post-procedure
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All patients underwent repeat pan-cerebral DSA at 1 year post-procedure; the degree of stenosis at the stent-implantation site was graded on the angiogram as mild (<50%), moderate (50%-70%), or severe (≥70%), and the proportion of patients with any degree of stenosis relative to the total cohort was calculated.
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At 1 year post-procedure
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mRS score at 1 year post-procedure
Prazo: At 1 year post-procedure
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The mRS score at the 1-year post-procedure cerebral angiography visit was assessed; if the patient could not attend, the score was obtained via outpatient clinic or structured telephone interview.
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At 1 year post-procedure
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
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Datas Principais do Estudo
Início do estudo (Real)
1 de janeiro de 2026
Conclusão Primária (Estimado)
1 de outubro de 2026
Conclusão do estudo (Estimado)
1 de agosto de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
22 de dezembro de 2025
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de junho de 2026
Primeira postagem (Real)
6 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
6 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de junho de 2026
Última verificação
1 de dezembro de 2025
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- K202507-31
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
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