AneurysmsPhase 4NCT07372612
Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms
A Phase 4 study testing Flow diverter and Stent-assisted coiling in people with Aneurysms and Flow Diverter, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Aneurysms, Flow Diverter, Middle Cerebral Artery Aneurysm
- What is being tested?
- Flow diverter and Stent-assisted coiling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 15 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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
- Being tested
- Flow diverter, Stent-assisted coiling
- Medical subject headings
- Aneurysm, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow diverterProcedure or surgery
Flow diverter (FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed
Stent-assisted coilingProcedure or surgery
Conventional stent-assisted coil embolization was performed (with preferential use of an LVIS stent)
| Study group | Role | What they receive |
|---|---|---|
| Flow diverter treatment group | Experimental | Flow diverter（FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed. Receives: Procedure: Flow diverter |
| Stent-assisted coiling treatment group | Active comparator | Underwent conventional stent-assisted coiling (preferentially using an LVIS stent) Receives: Procedure: Stent-assisted coiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete occlusion rate of middle cerebral artery bifurcation aneurysms at 1-year follow-up (assessed according to the Raymond-Roy Classification)
Measured: 1 year
Secondary outcomes (5)
The rate of aneurysm recurrence at 1-year post-procedure
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 year
Total interventional procedure time (from puncture to completion of the procedure)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start20 Jan 2026 (estimated)
- Primary completion15 Oct 2027 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmsStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, 庄宗, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372612
- Sponsor's protocol ID
- 2025-LCYJ-MS-11
- Status last verified
- Oct 2025
- First submitted
- 8 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Flow-diverting Devices for the Treatment of Middle Cerebral Artery Bifurcation Aneurysms
- ClinicalTrials.gov ID
- NCT07372612
- Acronym / sponsor ID
- 2025-LCYJ-MS-11
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow diverter treatment group | Experimental | Procedure: Flow diverterFlow diverter（FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed. |
| Stent-assisted coiling treatment group | Active comparator | Procedure: Stent-assisted coilingUnderwent conventional stent-assisted coiling (preferentially using an LVIS stent) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flow diverterFlow diverter (FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed | Procedure or surgery | Flow diverter treatment group |
| Stent-assisted coilingConventional stent-assisted coil embolization was performed (with preferential use of an LVIS stent) | Procedure or surgery | Stent-assisted coiling treatment group |
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Flow diverter and Stent-assisted coiling in people with Aneurysms and Flow Diverter, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zong zhuang (86+15850560410, zhuangzong@njglyy.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.