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

a Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Registration Trial of the Intracranial Stent for the Treatment of Intracranial Aneurysms: Rebridge

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Diseases; Aneurysm; Intracranial Aneurysm
• Intervention / Treatment: Device: Intracranial stent for wide-necked aneurysms

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huina Lu; Phone Number: 15901703529; Email: HuiNa.Lu@microport.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • First Affiliated Hospital of Zhengzhou University
      • Contact: Sheng Guan; Email: gsradio@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years； Target aneurysms was diagnosed as intracranial widenecked saccular aneurysms by DSA/CTA/MRA； The target aneurysm should be suitable for stentassisted coiling surgery and could be treated through one operation； Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily.

Exclusion Criteria:

• Aneurysms unsuitable for stent-assisted coiling (i.e. aneurysm necks ≤ 4 mm and or body-to-neck ratio ≥ 2)； The distal diameter of the aneurysm-carrying artery is outside the range of application of the investigational device; mRS score ≥3; Subjects with recurrent aneurysms treated by stent-assisted coiling; Multiple aneurysms and all aneurysms requiring intervention; Subjects with ruptured aneurysms <30 days ; Significant stenosis (≥50%) or occlusion of parent artery; Subjects unsuitable for anaesthesia 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 vital organs, etc.) within 30 days prior to signing the informed consent form, or scheduled to 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, aortic coarctation, limited vascular access (e.g., severe intracranial vascular tortuosity, severe intracranial vasospasm unresponsive to medication, other anatomical or clinical pathologies that would prevent access to the device); Contraindications to stenting, including but not limited to: contraindication to DSA, allergy or intolerance to contrast media, allergy or intolerance to antiplatelet and anticoagulant medications required for treatment, allergy to nickel-titanium and platinum-tungsten and platinum-iridium alloys; Pregnant or breastfeeding women; Life expectancy less than 12 months; Subject participation in other drug or device studies that do not meet endpoints

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Microport NeuroTech Intracranial Visualized Stent	Device: Intracranial stent for wide-necked aneurysms; Intracranial stent for wide-necked aneurysms
Active Comparator: Control group; LVIS™ and LVIS™ Jr	Device: Intracranial stent for wide-necked aneurysms; Intracranial stent for wide-necked aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of aneurysms with adequate occlusion	The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Adequate occlusion rate includes Class I and Class II	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of stent technical success	Technical successwas defined as the stent was successfully released at the appropriate position, and covered the aneurysm's neck completely while the parent artery remained unobstructed postoperatively.	immediately after the procedure
Rate of aneurysms with complete occlusion	The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Complete occlusion rate includes Class I	6 months
Rate of in-stent stenosis (≥50%)		6 months
Rate of aneurysms with adequate occlusion		1 year
Rate of aneurysms with complete occlusion		1 year
Rate of aneurysms with retreatment	Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up	1 year

Collaborators and Investigators

• Sponsor: MicroPort NeuroTech Co., Ltd.
• Investigators: Principal Investigator: Sheng Guan, the First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Brain Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: Mermaid-2023-01-CIP-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No