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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTang-Du Hospital

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 volunteers

Qualifiers

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

Design model

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/Surgery

    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.

Treatment groups

174 Participants
are divided into 1 treatment group
Group A: We will perform stent-assisted embolization on patients who meet the inclusion criteria.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From the procedure to 30 days post-procedure
2

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.

Time frame
from the start of the procedure to postoperative day 30.

Secondary outcomes

1

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.

Time frame
Immediately post-procedure
2

30-day post-procedure mRS score

Time frame
From immediately post-procedure to post-operative day 30
3

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.

Time frame
From the post-operative period up to 1 year post-procedure
4

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.

Time frame
From 1 month to 1 year post-procedure

Other outcomes

Sponsors and contacts

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