Skip to content

Prospective registration study of interventional therapy for acute intracranial ruptured wide necked aneurysms

Prospective registration study of interventional therapy for acute intracranial ruptured wide necked aneurysms

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037546
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intracranial aneurysm

Interventions

Case series:stent implantation

Sponsors

Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Subarachnoid hemorrhage clearly diagnosed by CT or lumbar puncture within 28 days after onset; 2. Subject aged 18 to 75 years old; 3. For intracranial ruptured wide-neck aneurysms confirmed by DSA, the aneurysmal neck width >=4 mm or body-neck ratio 6 months; 6. Subjects or their family members agree to sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with intracranial ruptured aneurysm with intracranial hematoma; 2. The subject has other intracranial vascular malformations, such as AVM and AVF; 3. Aneurysms associated with blood vesicles, dissection, fusiform, traumatic, infectious or cerebrovascular malformations; 4. Ruptured aneurysms already treated; 5. Aneurysms treated with simple stent implantation, aneurysm bearing artery occlusion or other non-detachable coil embolization materials; 6. Subjects with malignant tumors in intracranial or other parts of the body; 7. Disabled before stroke, which may interfere with the functional outcome assessment 1 year after surgery, namely mRS > 2; 8. People with severe mental illness are unable to communicate when diagnosing their illness; 9. Patients with poor systemic condition, life expectancy less than 1 year or poor physical condition, unable to tolerate general anesthesia or aneurysm surgery; 10. Patients who cannot receive antiplatelet aggregation or anticoagulation therapy, or have abnormal coagulation function; 11. Patients with contrast agent allergy or intolerance; 12. Subjects who have participated in clinical trials of other drugs or medical devices before being enrolled and have not reached the time limit of the main study endpoint; 13. The investigator considers it inappropriate to participate in or continue to participate in this clinical trial; 14. Patients who did not receive complete follow-up; 15. Pregnant women and women who are planning to become pregnant during follow-up; 16. A history of drug abuse or a patient with drug abuse during follow-up; 17. Major surgeries planned within 30 days of inclusion or 90 days after inclusion

Design outcomes

Primary

MeasureTime frame
safety;

Countries

China

Contacts

Public ContactQiao Zuo

Changhai Hospital, Naval Medical University, PLA

dr_zuo@126.com+86 136 2181 7430

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026