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

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.

Study Overview

• Status: Recruiting
• Conditions: Efficacy and Safety; Ruptured Aneurysm of Intracranial Artery; Stent-Assisted Coiling
• Intervention / Treatment: Procedure: Perform stent-assisted aneurysm embolization on patients who meet the enrollment criteria, and administer antiplatelet drugs postoperatively according to the established trial protocol.

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.

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038
      • Contact: Jian Ping Deng,M.D Ph.D;+86 13991139395;13991139395@163.com Zhen Wei Zhao,M.D Ph.D; Phone Number: +8613991139395; Email: 13991139395@163.com
      • Contact: Tao Zhang,M.D Ph.D; Phone Number: +8613519150673; Email: baltimore@163.com
      • Sub-Investigator: Wei Fang,M.D Ph.D Fang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: We will perform stent-assisted embolization on patients who meet the inclusion criteria.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the procedure to 30 days post-procedure
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.	from the start of the procedure to postoperative day 30.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately post-procedure
30-day post-procedure mRS score		From immediately post-procedure to post-operative day 30
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.	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	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	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	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

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: K202507-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No