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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Aneurysms; Middle Cerebral Artery Aneurysm; Flow Diverter; Coiling Therapy
• Intervention / Treatment: Procedure: Flow diverter; Procedure: Stent-assisted coiling

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: zong zhuang; Phone Number: 86+15850560410; Email: zhuangzong@njglyy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flow diverter treatment group; Flow diverter（FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed.	Procedure: Flow diverter; Flow diverter (FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed
Active Comparator: Stent-assisted coiling treatment group; Underwent conventional stent-assisted coiling (preferentially using an LVIS stent)	Procedure: Stent-assisted coiling; Conventional stent-assisted coil embolization was performed (with preferential use of an LVIS stent)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	The modified Rankin Scale (mRS) measures the degree of disability or dependence in the daily activities of patients. A score of 0 indicates no symptoms at all, score of 1 indicates no significant disability despite symptoms, score of 2 indicates slight disability, score of 3 indicates moderate disability, score of 4 indicates moderately severe disability, score of 5 indicates severe disability, and score of 6 indicates death.	1 year
Patients' cognitive outcomes at 6 months and 1 year post-procedure (MMSE scores)	The Mini-mental state examination（MMSE） examination includes time and place orientation, registration,attention and calculation, recall, language,repitition, complex commands. Score excess 24 or more indicates a normal cognition, 19-23 points indicates mild cognitive impairment, score of 10-18 points indicates moderate cognitive impairment and score below 9 points indicates severe cognitive impairment	1 year
Incidence of Branch Vessel Patency and In-stent Stenosis Assessed by Digital Subtraction Angiography (DSA)	Branch vessel patency (specifically the covered M2 branches) will be evaluated using follow-up DSA images and classified as patent, narrowed, or occluded. In-stent stenosis is defined as a narrowing of the vessel diameter >50% within the stented segment compared to the reference vessel diameter.	1 year
Total interventional procedure time (from puncture to completion of the procedure)		1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): October 15, 2028

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 2025-LCYJ-MS-11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No