NCT07372612

Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms

A Prospective Randomized Controlled Trial of Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if flow diverter (FD) offers advantages over conventional stent-assisted coiling in the treatment of middle cerebral artery (MCA) bifurcation aneurysms . It will also learn about the safety of flow diverter (FD) treatment. The main questions it aims to answer are: Does flow diverter (FD) treatment improves the rate of complete aneurysm occlusion and patients' neurological function? Does flow diverter (FD) treatment loweres the probability of aneurysm recurrence and the occurrence of complications? Researchers will compare FD to a conventional stent-assisted coiling to see if FD treatment works better to treat MCA bifurcation aneurysms. Participants will: Undergo stent-assisted coiling or flow diverter treatment Take pre-operative and pre-discharge head MRI scans, neurological function assessments, and cognitive function assessments Visit the clinic 1 year for checkups and tests

Conditions

• Aneurysms
• Flow Diverter
• Middle Cerebral Artery Aneurysm
• Coiling Therapy

Interventions

Type	Name	Description
PROCEDURE	Flow diverter	Flow diverter (FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed
PROCEDURE	Stent-assisted coiling	Conventional stent-assisted coil embolization was performed (with preferential use of an LVIS stent)

Timeline

• Start date: 2026-01-20
• Primary completion: 2027-10-15
• Completion: 2028-10-15
• First posted: 2026-01-28
• Last updated: 2026-01-28