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NCT Number: NCT07372612

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

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Key information

Conditions

Aneurysms Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coiling Therapy Flow Diverter Intracranial Aneurysm Intracranial Arterial Diseases Middle Cerebral Artery Aneurysm Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flow diverter

Procedure

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

Stent-assisted coiling

Procedure

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

Primary outcomes

  1. 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 outcomes

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

    Time frame: 1 year

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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

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

    Time frame: 1 year

    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.

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

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

zong zhuang

CONTACT

[email protected]

86+15850560410

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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