Safety and Efficacy Analysis of Stent-assisted Coil Embolization in the Treatment of Acute Ruptured Intracranial Aneurysms in the Perioperative Period.
2026년 6월 28일 업데이트: 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.
연구 개요
상태
모병
상세 설명
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.
연구 유형
중재적
등록 (추정된)
174
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Shaanxi
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Xi'an, Shaanxi, 중국, 710038
- 모병
- Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038
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연락하다:
- Jian Ping Deng,M.D Ph.D;+86 13991139395;13991139395@163.com Zhen Wei Zhao,M.D Ph.D
- 전화번호: +8613991139395
- 이메일: 13991139395@163.com
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연락하다:
- Tao Zhang,M.D Ph.D
- 전화번호: +8613519150673
- 이메일: baltimore@163.com
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부수사관:
- Wei Fang,M.D Ph.D Fang
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure
기간: 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.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Degree of immediate post-operative aneurysm occlusion
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 1월 1일
기본 완료 (추정된)
2026년 10월 1일
연구 완료 (추정된)
2027년 8월 1일
연구 등록 날짜
최초 제출
2025년 12월 22일
QC 기준을 충족하는 최초 제출
2026년 6월 28일
처음 게시됨 (실제)
2026년 7월 6일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 28일
마지막으로 확인됨
2025년 12월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- K202507-31
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