Unruptured Intracranial Wide-neck Bifurcation Aneurysms
Conditions
Keywords
intracranial aneurysms, wide-neck, bifurcation, flow diverter, unruptured
Brief summary
Brief Summary： The goal of this clinical trial is to compare whether the traditional approach (stent-assisted coiling) is associated with a lower complication rate than flow diverter (Pipeline™) treatment for unruptured intracranial wide-neck bifurcation aneurysms. It will also evaluate the long-term imaging outcomes and safety of both treatments. The main questions it aims to answer are: * Does the traditional approach result in a lower rate of any stroke or all-cause death within one year after treatment compared to the flow diverter? * What medical problems do participants experience during and after each treatment? * What are the imaging cure and stability rates at 1, 2, and 5 years after treatment? Researchers will compare the traditional approach (stent-assisted coiling) with the flow diverter (Pipeline™) to determine which treatment has better safety and efficacy outcomes. Participants will: * Be randomly assigned to receive either the flow diverter or traditional stent-assisted coiling * Undergo the assigned endovascular procedure * Return for follow-up visits at 30 days, 6 months, 1 year, 2 years, and 5 years after surgery for clinical assessments and imaging examinations (DSA, MRA, or CTA)
Interventions
DEVICEFlow Diverter Group
Flow diversion with the Pipeline™ (Flex/Shield) device for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the experimental group.
DEVICEStent Assisted Coiling Group
Stent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.
Sponsors
Nanfang Hospital, Southern Medical University
Shenzhen Second People's Hospital
Guangdong Provincial People's Hospital
Liv Hospital Ankara
ZhuHai Hospital
West China Hospital
Beijing Tiantan Hospital
Henan Provincial People's Hospital
Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Guangdong Second Provincial People's Hospital
The First Affiliated Hospital of Zhengzhou University
Xuanwu Hospital, Beijing
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years; 2. Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA; 3. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.
Exclusion criteria
1. Patients with two or more multiple aneurysms that all require treatment within 1 year; 2. Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease; 3. Ruptured aneurysms and narrow-neck aneurysms; 4. Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month; 5. Extremely poor clinical condition, modified Rankin Score ≥3; 6. Patients already scheduled for surgery/interventional procedure within 3 months; 7. Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent); 8. Patients unsuitable for anesthesia or endovascular surgery, such as major diseases of heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, severe mental illness; 9. Patients unable to receive antiplatelet or anticoagulant therapy; 10. Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication; 11. Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials; 12. Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe; 13. Pregnant or breastfeeding women; 14. Patient's life expectancy less than 12 months; 15. Investigator judges that the patient has poor compliance and cannot complete the study as required.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications at 1 year postoperatively in patients treated with different modalities. | 1 year | Any stroke, all-cause death events within 1 year post-surgery. Definitions: 1. Stroke defined as: acute focal or global neurological dysfunction due to vascular injury of brain, spinal cord or retina caused by hemorrhage or infarction, symptom duration ≥24 hours, including symptomatic branch stenosis/occlusion due to branch coverage; 2. TIA: transient focal neurological dysfunction due to brain, spinal cord or retinal ischemia, symptom duration \<24 hours, without acute infarction; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aneurysm occlusion rate and stability rate after different treatment modalities. | 5 years | Imaging cure rate （Raymond-Roy grade I) at 1, 2, and 5 years post-surgery. Definitions: Raymond-Roy grade: Class I: complete occlusion, no contrast filling in sac or neck; Class II: neck remnant, sac obliterated, contrast in neck; Class III: aneurysm remnant, contrast in sac. |
Countries
China
Contacts
CONTACTHuibin Kang, MD
CONTACTWenfeng Feng, MD
Outcome results
None listed