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Recruiting NCT07707076

Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)

Conditions: Unruptured Intracranial Wide-neck Bifurcation Aneurysms

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: NA
Enrollment: 266
Sponsor: Nanfang Hospital, Southern Medical University

Location: Nanfang Hospital, Southern Medical University Guangzhou Guangdong

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)

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07707076). StuddyBuddy aggregates publicly available trial information.