Safety and Efficacy Analysis of Stent-assisted Coil Embolization in the Treatment of Acute Ruptured Intracranial Aneurysms in the Perioperative Period.
28 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
174
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Shaanxi
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Xi'an, Shaanxi, Chine, 710038
- Recrutement
- Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038
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Contact:
- Jian Ping Deng,M.D Ph.D;+86 13991139395;13991139395@163.com Zhen Wei Zhao,M.D Ph.D
- Numéro de téléphone: +8613991139395
- E-mail: 13991139395@163.com
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Contact:
- Tao Zhang,M.D Ph.D
- Numéro de téléphone: +8613519150673
- E-mail: baltimore@163.com
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Sous-enquêteur:
- Wei Fang,M.D Ph.D Fang
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure
Délai: 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.
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Degree of immediate post-operative aneurysm occlusion
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 janvier 2026
Achèvement primaire (Estimé)
1 octobre 2026
Achèvement de l'étude (Estimé)
1 août 2027
Dates d'inscription aux études
Première soumission
22 décembre 2025
Première soumission répondant aux critères de contrôle qualité
28 juin 2026
Première publication (Réel)
6 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 juin 2026
Dernière vérification
1 décembre 2025
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- K202507-31
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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