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Not yet recruiting NCT07372612

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

Phase IV Interventional Aneurysms Flow Diverter Middle Cerebral Artery Aneurysm Coiling Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Flow diverter, Stent-assisted coiling.
Who it may be relevant to
Registry conditions: Aneurysms, Flow Diverter, Middle Cerebral Artery Aneurysm, Coiling Therapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

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)

Primary outcome measures

  • Complete occlusion rate of middle cerebral artery bifurcation aneurysms at 1-year follow-up (assessed according to the Raymond-Roy Classification) [Time frame: 1 year]
Secondary outcome measures (5)
  • The rate of aneurysm recurrence at 1-year post-procedure [Time frame: 1 year]
  • Patients' neurological outcomes at 6 months and 1 year post-procedure (mRS scores and Mini-mental state examination) [Time frame: 1 year]
  • Patients' cognitive outcomes at 6 months and 1 year post-procedure (MMSE scores) [Time frame: 1 year]
  • Incidence of Branch Vessel Patency and In-stent Stenosis Assessed by Digital Subtraction Angiography (DSA) [Time frame: 1 year]
  • Total interventional procedure time (from puncture to completion of the procedure) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07372612 · 2025-LCYJ-MS-11

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗