About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Perform stent-assisted aneurysm embolization on patients who meet the enrollment criteria, and administer antiplatelet drugs postoperatively according to the established trial protocol.
Procedure/Surgery1\. 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.
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with imaging-confirmed stent-related stroke within 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.
Number of participants with perioperative NIHSS score ≥4 or all-cause mortality.
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.
Secondary outcomes
Degree of immediate post-operative aneurysm occlusion
Immediate post-embolization angiography was performed to assess the degree of aneurysm occlusion using the Raymond grading system.
30-day post-procedure mRS score
Degree of aneurysm occlusion at 1 year post-operation
All patients underwent repeat pan-cerebral DSA at 1 year post-operation; angiographic findings were classified as no recurrence, mild recurrence, or significant recurrence.
Treatment-related ischemic or hemorrhagic events occurring between 1 month and 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.
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