Multicenter Study to Evaluate the Effectiveness and Safety of Flow-Diverting Stents for Distal Intracranial Aneurysms

ConditionAneurysms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

obtained from the treatment of intracranial distal intracranial aneurysms with flow diverter

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention measures

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Complete occlusion rate of aneurysm 12 months after surgery

Time frame
12 months after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

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