Recruiting NCT07376590
Multicenter Study to Evaluate the Effectiveness and Safety of Flow-Diverting Stents for Distal Intracranial Aneurysms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention measures.
- Who it may be relevant to
- Registry conditions: Aneurysms. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device No intervention measures
No intervention measures, 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.
Primary outcome measures
- Complete occlusion rate of aneurysm 12 months after surgery [Time frame: 12 months after surgery]
Eligibility criteria
Inclusion criteria
- Age 18 to 80 years, any gender，Subjects who have accepted treatment with flow-diverting for distal intracranial aneurysms
- 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).
- 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
- 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.)
- mRS score ≥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.)
- Platelet count <60×10\^9/L, known platelet dysfunction, or international normalized ratio (INR) >1.5
- Major surgery within 30 days before enrollment，or planned to undergo surgery within 360 days after enrollment
- Known allergies or contraindications to anesthetics, anticoagulants, and antiplatelet drugs
- Pregnant or breastfeeding women
- Subject has participated in other clinical trials within 1 month before signing informed consent
- Other conditions judged by the investigators as unsuitable for enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- First Affiliated Hospital of Zhejiang University — Hangzhou
Identifiers
NCT: NCT07376590 · FESTR-DAN