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

NCT07683377 | Recruiting

• 1 other identifier: K202507-31
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Ruptured Aneurysm of Intracranial Artery; Stent-Assisted Coiling; Efficacy and Safety

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Degree of immediate post-operative aneurysm occlusion

  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

  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

  From 1 month to 1 year post-procedure

• Proportion of in-stent restenosis at 1 year post-procedure

  At 1 year post-procedure

Study Arms (1)

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

EXPERIMENTAL

Procedure: Perform stent-assisted aneurysm embolization on patients who meet the enrollment criteria, and administer antiplatelet drugs postoperatively according to the established trial protocol.

Interventions

Perform stent-assisted aneurysm embolization on patients who meet the enrollment criteria, and administer antiplatelet drugs postoperatively according to the established trial protocol. PROCEDURE

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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038

Xi'an, Shaanxi, 710038, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: July 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)