NCT07376590 Multicenter Study to Evaluate the Effectiveness and Safety of Flow-Diverting Stents for Distal Intracranial Aneurysms
| NCT ID | NCT07376590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Aneurysms |
| Study Type | OBSERVATIONAL |
| Enrollment | 164 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 164 participants in total. It began in 2026-01-15 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Using data obtained from the treatment of intracranial distal intracranial aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of distal intracranial aneurysms.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 to 80 years, any gender，Subjects who have accepted treatment with flow-diverting for distal intracranial aneurysms 2. Diagnosed with an intracranial aneurysm by CTA, MRA, or DSA, with the following features: a wide neck (≥4mm), or a dome-to-neck ratio \<2, saccular, fusiform aneurysms, recurrent saccular aneurysms, and dissecting aneurysms. Locations include: the Circle of Willis and it's distal branches such as the middle cerebral artery (MCA) M1-M3 segments, anterior cerebral artery (ACA) A1-A3 segments, posterior cerebral artery (PCA) P1-P2 segments, etc. (intracranial aneurysms of the Circle of Willis and it's distal vessels). 3. Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form Exclusion Criteria: 1. Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.) 2. mRS score ≥3 3. Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.) 4. Platelet count \<60×10\^9/L, known platelet dysfunction, or international normalized ratio (INR) \>1.5 5. Major surgery within 30 days before enrollment，or planned to undergo surgery within 360 days after enrollment 6. Known allergies or contraindications to anesthetics, anticoagulants, and antiplatelet drugs 7. Pregnant or breastfeeding women 8. Subject has participated in other clinical trials within 1 month before signing informed consent 9. Other conditions judged by the investigators as unsuitable for enrollment
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07376590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Aneurysms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07376590 currently recruiting?
Yes, NCT07376590 is actively recruiting participants. Contact the research team at y.shen@zju.edu.cn for enrollment information.
Where is the NCT07376590 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07376590 clinical trial?
NCT07376590 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 164 participants.