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

28 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

174

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Cina
    • Shaanxi
      • Xi'an, Shaanxi, Cina, 710038
        • Reclutamento
        • Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038
        • Contatto:
          • Jian Ping Deng,M.D Ph.D;+86 13991139395;13991139395@163.com Zhen Wei Zhao,M.D Ph.D
          • Numero di telefono: +8613991139395
          • Email: 13991139395@163.com
        • Contatto:
        • Sub-investigatore:
          • Wei Fang,M.D Ph.D Fang

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: We will perform stent-assisted embolization on patients who meet the inclusion criteria.
Procedura: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure
Lasso di tempo: From the procedure to 30 days post-procedure
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.
From the procedure to 30 days post-procedure
Number of participants with perioperative NIHSS score ≥4 or all-cause mortality.
Lasso di tempo: from the start of the procedure to postoperative day 30.
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.
from the start of the procedure to postoperative day 30.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Degree of immediate post-operative aneurysm occlusion
Lasso di tempo: Immediately post-procedure
Immediate post-embolization angiography was performed to assess the degree of aneurysm occlusion using the Raymond grading system.
Immediately post-procedure
30-day post-procedure mRS score
Lasso di tempo: From immediately post-procedure to post-operative day 30
From immediately post-procedure to post-operative day 30
Degree of aneurysm occlusion at 1 year post-operation
Lasso di tempo: From the post-operative period up to 1 year post-procedure
All patients underwent repeat pan-cerebral DSA at 1 year post-operation; angiographic findings were classified as no recurrence, mild recurrence, or significant recurrence.
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
Lasso di tempo: From 1 month to 1 year post-procedure
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.
From 1 month to 1 year post-procedure
Proportion of in-stent restenosis at 1 year post-procedure
Lasso di tempo: At 1 year post-procedure
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.
At 1 year post-procedure
mRS score at 1 year post-procedure
Lasso di tempo: At 1 year post-procedure
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.
At 1 year post-procedure

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Tang-Du Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 gennaio 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

22 dicembre 2025

Primo inviato che soddisfa i criteri di controllo qualità

28 giugno 2026

Primo Inserito (Effettivo)

6 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 giugno 2026

Ultimo verificato

1 dicembre 2025

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • K202507-31

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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