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

NCT07372612 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025-LCYJ-MS-11
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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; Coiling Therapy; Middle Cerebral Artery Aneurysm

Outcome Measures

Primary Outcomes (1)

• Complete occlusion rate of middle cerebral artery bifurcation aneurysms at 1-year follow-up (assessed according to the Raymond-Roy Classification)

  1 year

Secondary Outcomes (5)

• The rate of aneurysm recurrence at 1-year post-procedure

  1 year

• Patients' neurological outcomes at 6 months and 1 year post-procedure (mRS scores and Mini-mental state examination)

  1 year

• Patients' cognitive outcomes at 6 months and 1 year post-procedure (MMSE scores)

  1 year

• Incidence of Branch Vessel Patency and In-stent Stenosis Assessed by Digital Subtraction Angiography (DSA)

  1 year

• Total interventional procedure time (from puncture to completion of the procedure)

  1 year

Study Arms (2)

Flow diverter treatment group

EXPERIMENTAL

Flow diverter（FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed.

Procedure: Flow diverter

Stent-assisted coiling treatment group

ACTIVE COMPARATOR

Underwent conventional stent-assisted coiling (preferentially using an LVIS stent)

Procedure: Stent-assisted coiling

Interventions

Flow diverter PROCEDURE

Flow diverter (FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed

Flow diverter treatment group

Stent-assisted coiling PROCEDURE

Conventional stent-assisted coil embolization was performed (with preferential use of an LVIS stent)

Stent-assisted coiling treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unruptured wide-necked middle cerebral artery bifurcation aneurysms definitively diagnosed by CTA or DSA;
• Aneurysms requiring stent-assisted embolization with the necessity of preserving branch arteries;
• Indication for either flow diversion device or conventional stent-assisted coiling;
• Age between 18 and 70 years, inclusive;
• The subject or their legally authorized representative has signed the written informed consent form.

You may not qualify if:

• Concomitant significant organ dysfunction (e.g., severe cardiac, hepatic, or renal insufficiency), chronic inflammatory disease, or malignancy;
• Pregnant or lactating women;
• Presence of significant neurological deficit (mRS score \> 2);
• Presence of contraindications to flow diversion device or stent-assisted coiling (e.g., severe allergy to metallic material, contraindication to antiplatelet medication);
• Other conditions deemed unsuitable for enrollment by the investigator.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Aneurysm; Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

zong zhuang

CONTACT

86+15850560410; zhuangzong@njglyy.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician of Neurosurgery, Principal Investigator

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 28, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2028
• Last Updated: January 28, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share