Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
Location contact
Huibin Kang, MD
CONTACT
Wenfeng Feng, MD
CONTACT
NCT Number: NCT07707076
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)
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510515, China
Location status: Recruiting
Huibin Kang, MD
CONTACT
Wenfeng Feng, MD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Flow diversion with the Pipeline™ (Flex/Shield) device for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the experimental group.
Stent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.
Time frame: 1 year
Any stroke, all-cause death events within 1 year post-surgery.
Definitions:
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Huibin Kang, MD
CONTACT
Wenfeng Feng, MD
CONTACT
Nanfang Hospital, Southern Medical University
Other
Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)
Acronym: FD-BWA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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