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Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Huibin Kang, MD
kanghuibindoctor@163.com
+8602062787842
Backup
Wenfeng Feng, MD
fengwf1967@163.com
+8602062787665
Time Frame
Start Date: 2026-02-10
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 266
Treatments
Active_comparator: Stent Assisted Coiling Group
Traditional Group (Stent Assisted Coiling):~The patient is placed in a supine position. After satisfactory general anesthesia, the right groin area is routinely disinfected and draped. The right femoral artery sheath is replaced with an 8F sheath. Systemic heparinization is administered, followed by continuous pressurized infusion. A 6F long sheath plus a 5F multifunction catheter are advanced with a Terumo guidewire, and the long sheath is positioned in the left vertebral artery. A micro guidewire is used with a microcatheter to selectively catheterize the left posterior cerebral artery P2 segment, and then the microcatheter is advanced into the aneurysm. Through the microcatheter, one coil is semi deployed to form a framing coil, then one stent is deployed through the stent catheter to cover the aneurysm neck. After the first framing coil is detached, several additional coils are sequentially deployed to embolize the aneurysm. Follow up angiography shows no opacification of the a
Experimental: Flow Diverter Group
Flow Diverter Group:~The patient is placed in a supine position. The right groin area is routinely disinfected and draped. Local infiltration anesthesia is applied at the puncture site, and the right femoral artery is punctured using the Seldinger technique. An 8F sheath is inserted, systemic heparinization is administered, and continuous pressurized infusion is started. A 6F long sheath is advanced to the origin of the right internal carotid artery with the assistance of a Terumo guidewire and a multifunction catheter. A 5F intermediate catheter is advanced inside the long sheath to the petrous segment of the right internal carotid artery. 3D cerebral angiography is performed, and after a suitable working angle is obtained, a stent catheter is advanced to the right middle cerebral artery M3 segment with micro guidewire assistance. Manual injection shows no hemorrhage, confirming the true lumen. After calibration and measurement, one flow diverter stent is deployed to cover the ane
Related Therapeutic Areas
Sponsors
Collaborators: The First Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital, Xuanwu Hospital, Beijing, West China Hospital, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand, Shenzhen Second People's Hospital, Guangdong Provincial People's Hospital, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China, Liv Hospital Ankara, Beijing Tiantan Hospital, ZhuHai Hospital, Guangdong Second Provincial People's Hospital
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov