Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE

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

This trial was designed as a prospective, multicentre, open, non-inferiority, randomised controlled clinical trial, with the control devices being MicroVention's LVIS Intraluminal Support Device and LVIS Jr. Intraluminal Support Device. Approximately 200 subjects with intracranial aneurysms would be enrolled for stent-assisted coiling embolisation according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±60 days) postoperatively; subjects would underwent DSA imaging at surgery and at 6 months (±30 days) postoperatively, and MRA or DSA imaging at 12 months (±60 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of intracranial artery stent for stent-assisted coiling embolisation for the treatment of intracranial aneurysms.

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
    China

    Active - Recruiting

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