Safety and Efficacy Analysis of Stent-assisted Coil Embolization in the Treatment of Acute Ruptured Intracranial Aneurysms in the Perioperative Period.

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Perform stent-assisted aneurysm embolization on patients who meet the enrollment criteria, and administer antiplatelet drugs postoperatively according to the established trial protocol.
  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.

Первичные конечные точки

• Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure [Срок оценки: From the procedure to 30 days post-procedure]
• Number of participants with perioperative NIHSS score ≥4 or all-cause mortality. [Срок оценки: from the start of the procedure to postoperative day 30.]

Вторичные конечные точки (6)

• Degree of immediate post-operative aneurysm occlusion [Срок оценки: Immediately post-procedure]
• 30-day post-procedure mRS score [Срок оценки: From immediately post-procedure to post-operative day 30]
• Degree of aneurysm occlusion at 1 year post-operation [Срок оценки: From the post-operative period up to 1 year post-procedure]
• Treatment-related ischemic or hemorrhagic events occurring between 1 month and 1 year post-procedure [Срок оценки: From 1 month to 1 year post-procedure]
• Proportion of in-stent restenosis at 1 year post-procedure [Срок оценки: At 1 year post-procedure]
• mRS score at 1 year post-procedure [Срок оценки: At 1 year post-procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038 — Сиань

Идентификаторы

NCT: NCT07683377 · K202507-31

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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