Not yet recruiting NCT07205302

Safety and Efficacy of the Flow Diverter in the Treatment of Intracranial Non-saccular Aneurysm

— Observational Intracranial Non-saccular 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: flow diverter.
Who it may be relevant to: Registry conditions: Intracranial Non-saccular 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: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Using data obtained from the treatment of intracranial non-saccular aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of intracranial non-saccular aneurysms.

Interventions

Device flow diverter
the treatment of intracranial non-saccular aneurysms with flow diverter

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
Diagnosed as a non-saccular aneurysm in the patient's intracranial region
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

Aneurysm rupture within 30 days before enrollment;
Diagnosis of multiple aneurysms and requiring reoperation within 12 months
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.);
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.);
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;
Known allergy to nickel-titanium alloy metal materials;
Life expectancy <12 months;
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.

Study design

Observational model: Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07205302 · RJSW202504

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗