Safety and Efficacy Analysis of Stent-assisted Coil Embolization in the Treatment of Acute Ruptured Intracranial Aneurysms in the Perioperative Period.
2026年6月28日 更新者：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.
調査の概要
状態
募集
詳細な説明
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.
研究の種類
介入
入学 (推定)
174
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Shaanxi
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Xi'an、Shaanxi、中国、710038
- 募集
- Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038
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コンタクト：
- Jian Ping Deng,M.D Ph.D;+86 13991139395;13991139395@163.com Zhen Wei Zhao,M.D Ph.D
- 電話番号：+8613991139395
- メール：13991139395@163.com
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コンタクト：
- Tao Zhang,M.D Ph.D
- 電話番号：+8613519150673
- メール：baltimore@163.com
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副調査官：
- Wei Fang,M.D Ph.D Fang
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure
時間枠：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.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Degree of immediate post-operative aneurysm occlusion
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年1月1日
一次修了 (推定)
2026年10月1日
研究の完了 (推定)
2027年8月1日
試験登録日
最初に提出
2025年12月22日
QC基準を満たした最初の提出物
2026年6月28日
最初の投稿 (実際)
2026年7月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月6日
QC基準を満たした最後の更新が送信されました
2026年6月28日
最終確認日
2025年12月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- K202507-31
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