Stent-assisted Coil Embolization for Acute Ruptured Intracranial Aneurysms
Official title: Safety and Efficacy Analysis of Stent-assisted Coil Embolization in the Treatment of Acute Ruptured Intracranial Aneurysms in the Perioperative Period.
Run by Tang-Du Hospital · NCT07683377 · Data updated 2026-11-12
This study tests whether stent-assisted coil embolization for ruptured intracranial aneurysms can be safely used in the acute period and help prevent rebleeding.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | Tang-Du Hospital Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | October 1, 2026 |
| Study ends | August 1, 2027 |
| Registry record updated | July 6, 2026 |
| Trial ID | NCT07683377 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-80 with a single ruptured intracranial aneurysm (or a clearly responsible lesion in multiple aneurysms) with wide necks suitable for stent-assisted embolization, treated within 7 days of hemorrhage.
✕Probably not a fit
Patients with non-cystic aneurysms, inaccessible anatomy, or those unable to receive intravenous antiplatelet therapy may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates the perioperative safety and effectiveness of stent-assisted coil embolization for acute ruptured intracranial aneurysms. Patients receive a stent and coils, with postoperative intravenous antiplatelet therapy guided by a predefined protocol. Primary endpoints include perioperative complications, new ischemic or bleeding events within 30 days, and perioperative mortality. Secondary endpoints assess immediate embolization grade, 30-day functional status, and long-term aneurysm occlusion and restenosis up to one year. The trial aims to determine if this approach provides a safe and effective option for patients requiring urgent interventional treatment.
Why it matters
Potential benefit: If successful, patients may have lower risk of rebleeding and better long-term aneurysm occlusion after an acute rupture.
How similar studies have gone: Previous research on stent-assisted coiling has shown promise in select ruptured aneurysm cases, but this trial addresses perioperative safety and efficacy in acute settings.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Tangdu Hospital,Fourth Military Medical University,Xi'an,Shaanxi 710038
Xi'an, Shaanxi, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.