Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)
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- 18 és 75 év között vagy?
Forrás: NCT07707076: ki vehet részt
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Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Nanfang Hospital, Southern Medical University
- Azonosító
- NCT07707076
- A regiszteradat frissítve
- 2026. július 16.
- Eredeti leírás
Brief Summary：A teljes eredeti leírásKevesebb
Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)
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)
Bevonási feltételek: Age 18-75 years; Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA; Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.
Kizáró feltételek: Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease; Patients already scheduled for surgery/interventional procedure within 3 months; Patients unable to receive antiplatelet or anticoagulant therapy; Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication; Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe; Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month; Extremely poor clinical condition, modified Rankin Score ≥3; 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; Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials; Patients with two or more multiple aneurysms that all require treatment within 1 year; Ruptured aneurysms and narrow-neck aneurysms; Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent); Pregnant or breastfeeding women; Patient's life expectancy less than 12 months; Investigator judges that the patient has poor compliance and cannot complete the study as required.