Intracranial aneurysm
Conditions
Interventions
Trail group:Aneuguide software assists in selecting FD models
control group:Manual selection of FD model
Sponsors
Eastern Theater Command General Hospital
Eligibility
Sex/Gender
All
Age
22 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 22 years old<=age<=80 years old, regardless of gender; 2. C2-C7 segments of ICA intracranial aneurysm(large, gigantic and broad-necked;adjacent multiple tandem; small and medium-sized confirmed by preoperative MRA, CTA, or DSA and planned for FD embolization treatment 3. The diameter of the aneurysm-carrying artery = 2 mm and = 5 mm 4.The subject or their guardian can understand the purpose of the experiment, have sufficient compliance with the protocol, and sign an informed consent form; 5. If there is no family planning within six months after signing the informed consent form, or if the pregnancy test for women of childbearing age is negative.
Exclusion criteria
Exclusion criteria: 1.Diagnosed as a vesicular, pseudo, infectious aneurysm or aneurysm related to arteriovenous malformations 2.Researchers believe that severe stenosis, tortuosity, or anatomical abnormalities of intracranial arteries make it difficult for instruments to reach the affected area; 3. Platelets (PLT)<60 × 109/L or contraindications to antiplatelet or/and anticoagulant therapy; 4. Have heart, lung, liver, and kidney failure or other serious diseases (such as intracranial tumors, systemic infections, disseminated intravascular coagulation, myocardial infarction within 12 months prior to enrollment, a history of severe mental illness, severe cerebral artery stenosis or occlusion, etc.); 5. The researcher assessed that the expected lifespan is less than 12 months and cannot complete the research cycle; 6. Pregnant or lactating women, or males or females with fertility plans within the next year; 7. Patients who have been determined by researchers to be unsuitable for embolization treatment of intracranial aneurysms due to various reasons; 8. Patients who are participating in research on other drugs or devices; 9. The patient refuses to sign the informed consent form, or is unable to cooperate in completing the required examinations and follow-up, or in other situations where the researcher determines that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Aneurysm occlusion rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Aneurysm recurrence rate;Duration of surgical procedure;X-ray exposure ;Incidence of intraoperative aneurysm rupture;The incidence of occlusion of the parent artery;Incidence of stroke;All-cause mortality;Adverse event occurrence rate;Serious adverse event occurrence rate;Adverse event of special interest occurrence rate;The incidence of additional intraoperative interventions;MRs scores immediately after surgery;MRs score before discharge;30 day postoperative mRs score;MRs score at 6 months post surgery;MRs score at 12 months post surgery; | — |
Countries
China
Contacts
Public ContactZhang Xin
Eastern Theater Command General Hospital
Outcome results
None listed