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

NCT07372612 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-01-28

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2027-10-15
Completion
2028-10-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07372612 on ClinicalTrials.gov