Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of 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: Intrasaccular Embolization Device.
- Who it may be relevant to
- Registry conditions: Intracranial Aneurysms. Basic parameters: 18 years — 75 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 →
Official title
Efficacy and Safety of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms : a Prospective, Multicenter, Single-arm Trial
Overview
The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.
Interventions
- Device Intrasaccular Embolization Device
This is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.The intended therapeutic effect of this device is to line the neck of the aneurysm with a metallic structure that disrupts the inflow of blood, causing hemostasis within the aneurysm sac, and leading to thrombus formation within the implant.
Primary outcome measures
- The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365. [Time frame: 12 months]
- Percentage of Subjects With Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Patient must be 18-75 years of age at the time of screening.
- Patient must have a single ruptured or unruptured IA requiring treatment.
- Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures.
Exclusion criteria
- Patient had an IA with characteristics unsuitable for endovascular treatment.
- Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device.
- Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
- Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation.
- Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
- Patient was pregnant.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07022249 · ZHTQ202501