Last updated: January 2, 2024
Sponsor: MicroPort NeuroTech Co., Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Aneurysm
Neurologic Disorders
Treatment
Intracranial stent for wide-necked aneurysms
Clinical Study ID
NCT06189950
Mermaid-2023-01-CIP-00
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- At the time of signing the informed consent form(ICF), the applicant shall be male ornon-pregnant female, aged 18 to 80 years; Target aneurysms was diagnosed asintracranial widenecked saccular aneurysms by DSA/CTA/MRA; The target aneurysm shouldbe suitable for stentassisted coiling surgery and could be treated through oneoperation; Subject or its legal representative should be able to understand thepurpose of this study, also agree to comply with protocol and sign the informedconsent form voluntarily.
Exclusion
Exclusion Criteria:
- Aneurysms unsuitable for stent-assisted coiling (i.e. aneurysm necks ≤ 4 mm and orbody-to-neck ratio ≥ 2); The distal diameter of the aneurysm-carrying artery isoutside the range of application of the investigational device; mRS score ≥3; Subjectswith recurrent aneurysms treated by stent-assisted coiling; Multiple aneurysms and allaneurysms requiring intervention; Subjects with ruptured aneurysms <30 days ;Significant stenosis (≥50%) or occlusion of parent artery; Subjects unsuitable foranaesthesia or endovascular surgical treatment, e.g. major diseases of the heart,lungs, liver, spleen and kidneys, brain tumours, severe active infections,disseminated intravascular coagulation, and a history of severe mental illness;Subjects undergoing major surgical procedures (e.g. tumour resection, surgery of vitalorgans, etc.) within 30 days prior to signing the informed consent form, or scheduledto undergo such procedures within 60 days after signing the informed consent form;Subjects with morphologies or pathologies that may interfere with device use,including, but not limited to: carotid artery coarctation, vasculitis, aorticcoarctation, limited vascular access (e.g., severe intracranial vascular tortuosity,severe intracranial vasospasm unresponsive to medication, other anatomical or clinicalpathologies that would prevent access to the device); Contraindications to stenting,including but not limited to: contraindication to DSA, allergy or intolerance tocontrast media, allergy or intolerance to antiplatelet and anticoagulant medicationsrequired for treatment, allergy to nickel-titanium and platinum-tungsten andplatinum-iridium alloys; Pregnant or breastfeeding women; Life expectancy less than 12months; Subject participation in other drug or device studies that do not meetendpoints
Study Design
Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Intracranial stent for wide-necked aneurysms
Phase:
Study Start date:
October 30, 2023
Estimated Completion Date:
October 30, 2026
Connect with a study center
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
ChinaActive - Recruiting
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