Safety and Efficacy Analysis of Stent-assisted Coil Embolization in the Treatment of Acute Ruptured Intracranial Aneurysms in the Perioperative Period.
28. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
174
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Shaanxi
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Xi'an, Shaanxi, Kina, 710038
- Rekruttering
- Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038
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Ta kontakt med:
- Jian Ping Deng,M.D Ph.D;+86 13991139395;13991139395@163.com Zhen Wei Zhao,M.D Ph.D
- Telefonnummer: +8613991139395
- E-post: 13991139395@163.com
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Ta kontakt med:
- Tao Zhang,M.D Ph.D
- Telefonnummer: +8613519150673
- E-post: baltimore@163.com
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Underetterforsker:
- Wei Fang,M.D Ph.D Fang
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure
Tidsramme: 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.
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Degree of immediate post-operative aneurysm occlusion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2026
Primær fullføring (Antatt)
1. oktober 2026
Studiet fullført (Antatt)
1. august 2027
Datoer for studieregistrering
Først innsendt
22. desember 2025
Først innsendt som oppfylte QC-kriteriene
28. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juni 2026
Sist bekreftet
1. desember 2025
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- K202507-31
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