Efficacy and Safety, Ruptured Aneurysm of Intracranial Artery, Stent-Assisted Coiling
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPerform 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.
Sponsors
Tang-Du Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with imaging-confirmed stent-related stroke within 30 days post-procedure | 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. |
| Number of participants with perioperative NIHSS score ≥4 or all-cause mortality. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of immediate post-operative aneurysm occlusion | Immediately post-procedure | Immediate post-embolization angiography was performed to assess the degree of aneurysm occlusion using the Raymond grading system. |
| 30-day post-procedure mRS score | From immediately post-procedure to post-operative day 30 | — |
| Degree of aneurysm occlusion at 1 year post-operation | 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. |
| Treatment-related ischemic or hemorrhagic events occurring between 1 month and 1 year post-procedure | 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. |
| Proportion of in-stent restenosis at 1 year post-procedure | 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. |
| mRS score at 1 year post-procedure | 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. |
Countries
China
Outcome results
None listed