Actively Recruiting
A Prospective, Multi-center, Open-label, Randomized Controlled Trial Comparing the Intracranial Visualized Stent and LVIS Devices for Treating Wide-necked Intracranial Aneurysms
Led by MicroPort NeuroTech Co., Ltd. · Updated on 2024-01-05
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new intracranial stent device for treating wide-necked intracranial aneurysms. This trial compares the new Microport NeuroTech Intracranial Visualized Stent with established devices called LVIS and LVIS Jr. The study aims to assess whether the new device is not inferior to current options in helping to close aneurysms. About 200 patients with intracranial aneurysms will participate in this prospective, randomized clinical trial across multiple centers. Participants will undergo stent-assisted coiling embolisation surgery using either the new Microport device or one of the control devices. The study is open-label and randomized, meaning patients are assigned to one of these treatment groups without masking. Follow-up will include imaging tests such as Digital Subtraction Angiography (DSA) and Magnetic Resonance Angiography (MRA) at surgery and at 6 and 12 months after surgery. The study carefully tracks the success of aneurysm occlusion and stent placement over time. Throughout the study, participants will be assessed before surgery, at device implantation, at hospital discharge, and at 1, 6, and 12 months post-surgery using the modified Rankin Scale (mRS) and imaging. Additional unplanned follow-ups may occur as needed. The main outcome measured is the rate of aneurysms with adequate occlusion at 6 months. Other outcomes include technical success of the stent, complete occlusion rates, in-stent narrowing, and the need for retreatment. Safety and efficacy will be monitored until the study ends in 2026.
CONDITIONS
Brief Title
Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or non-pregnant female aged 18 to 80 years
- Diagnosed with intracranial wide-necked saccular aneurysms by DSA, CTA, or MRA
- Aneurysm suitable for stent-assisted coiling surgery treatable in one operation
- Able to understand the study and voluntarily sign the informed consent form
You will not qualify if you...
- Aneurysms unsuitable for stent-assisted coiling (neck ≤ 4 mm or body-to-neck ratio ≥ 2)
- Distal artery diameter outside device range
- Modified Rankin Scale score ≥ 3
- Recurrent aneurysms previously treated by stent-assisted coiling
- Multiple aneurysms requiring intervention
- Ruptured aneurysms within last 30 days
- Significant stenosis (≥ 50%) or occlusion of parent artery
- Unsuitable for anesthesia or endovascular surgery due to major organ diseases, brain tumors, severe infections, or severe mental illness
- Major surgery within 30 days before or planned within 60 days after consent
- Anatomical or pathological conditions preventing device use
- Contraindications to stenting or contrast media
- Allergy to device materials or required medications
- Pregnant or breastfeeding women
- Life expectancy less than 12 months
- Participation in other drug or device studies not meeting endpoints
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo implantation of the intracranial stent device for treating wide-necked intracranial aneurysms in a single operation.
1 procedure visit (in-person)
Duration - Up to 1 year
Participants are monitored with follow-up visits to assess stent success, aneurysm occlusion, and safety outcomes.
Visits at immediately after procedure, 6 months, and 1 year
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
Research Team
H
Huina Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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