How blood flow changes after flow-diverter treatment for brain aneurysms
Hemodynamic Study of In-Stent Stenosis After Flow Diverter Implantation for Intracranial Aneurysms Based on 3D-DSA Combined With TCCD
We will test whether combining 3D angiography and transcranial Doppler can identify blood-flow thresholds linked to narrowing inside flow-diverter stents in adults treated for brain aneurysms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zhujiang Hospital Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06448949 on ClinicalTrials.gov |
What this trial studies
This single-center prospective cohort follows adults with intracranial aneurysms treated with flow diverters using 3D digital subtraction angiography (3D-DSA) and transcranial color-coded duplex (TCCD) sonography to measure hemodynamic changes. Patients undergo baseline and follow-up DSA (at least 1 month) and serial TCCD to detect and quantify in-stent stenosis and associated flow alterations. The team aims to determine whether specific blood-flow values predict the development or severity of in-stent narrowing. Cases with secondary aneurysms, prior surgical/endovascular repair, or aneurysm locations not accessible to TCCD are excluded.
Who should consider this trial
Good fit: Adults (≥18) with an intracranial aneurysm treated with a flow diverter who can undergo DSA and transcranial Doppler and return for at least one month of follow-up.
Not a fit: Patients with traumatic, infectious, AVM- or vasculitis-related aneurysms, previously treated recurrent aneurysms, aneurysms located where TCCD cannot detect flow, short expected survival, or contraindications to the devices/medications are unlikely to benefit.
Why it matters
Potential benefit: If successful, the findings could let clinicians use blood-flow measurements to predict and monitor in-stent narrowing and tailor follow-up or treatment to reduce complications.
How similar studies have performed: Prior work has described hemodynamic changes after flow-diverter placement, but using combined 3D-DSA and TCCD to define a predictive blood-flow threshold for in-stent stenosis is relatively novel and not yet established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age ≥ 18, male or non-pregnant female. Diagnosis of intracranial aneurysm confirmed by DSA (Digital Subtraction Angiography). Intracranial aneurysms treated with flow diverter (FD). DSA follow-up of at least 1 month. Exclusion Criteria: Secondary intracranial aneurysm cases: traumatic aneurysms, infectious aneurysms, or aneurysms associated with arteriovenous malformations (AVM) or vasculitis. Previously treated recurrent aneurysm or target aneurysm with craniotomy clipping surgery or other endovascular interventions. Aneurysms located at the distal end of the circle of Willis where TCCD (Transcranial Color-Coded Doppler) cannot be detected. Known familial clustering history. Expected survival less than 1 year. Preoperative clinical assessment with mRS (Modified Rankin Scale) score ≥ 3. Known allergy or contraindication to antiplatelet drugs, anticoagulants, contrast agents, anesthetics, nitinol memory alloy, platinum-tungsten alloy, or platinum-iridium alloy. Severe respiratory, hepatic, or renal disease (e.g., creatinine ≥ 3.0 mg/dL excluding dialysis) or coagulation disorders. Undergoing major surgery (e.g., limb fracture fixation, tumor resection, major organ surgery, etc.) within 30 days prior to signing informed consent or planned within 60 days after signing informed consent. Pregnant or lactating women, or women with a positive pregnancy test.
Where this trial is running
Guangzhou, Guangdong
- DuanChuanzhi — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Duan Chuan zhi, MD — Study Principal Investigator
- Study coordinator: Zhang Xin, MD
- Email: zhangxin19830818@163.com
- Phone: 15989058895
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.