Aneurysms, Coiling Therapy, Flow Diverter, Middle Cerebral Artery Aneurysm
Conditions
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
Interventions
PROCEDUREFlow diverter
Flow diverter (FD, preferentially a Lattice stent) placement, with adjunctive minimal coiling of the aneurysm sac as needed
PROCEDUREStent-assisted coiling
Conventional stent-assisted coil embolization was performed (with preferential use of an LVIS stent)
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Patients' cognitive outcomes at 6 months and 1 year post-procedure (MMSE scores) | 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 |
| Incidence of Branch Vessel Patency and In-stent Stenosis Assessed by Digital Subtraction Angiography (DSA) | 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. |
| Total interventional procedure time (from puncture to completion of the procedure) | 1 year | — |
Contacts
CONTACTzong zhuang
Outcome results
None listed