Actively Recruiting
Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE
Led by MicroPort NeuroTech Co., Ltd. · Updated on 2024-01-05
200
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 at the time of consent
- Diagnosed with intracranial wide-necked saccular aneurysm by DSA, CTA, or MRA
- Aneurysm suitable for stent-assisted coiling surgery treatable in one operation
- Able to understand study purpose, comply with protocol, and provide informed consent
You will not qualify if you...
- Aneurysms unsuitable for stent-assisted coiling (aneurysm neck ≤ 4 mm or body-to-neck ratio ≥ 2)
- Distal diameter of aneurysm-carrying artery outside device use range
- Modified Rankin Scale (mRS) score ≥ 3
- Recurrent aneurysms previously treated by stent-assisted coiling
- Multiple aneurysms requiring intervention for all
- Ruptured aneurysms within 30 days prior
- Significant stenosis (≥ 50%) or occlusion of parent artery
- Unsuitable for anesthesia or endovascular surgery due to major heart, lung, liver, spleen, kidney diseases, brain tumors, severe infections, coagulopathy, or severe mental illness
- Major surgery within 30 days prior or planned within 60 days after consent
- Morphologies or pathologies interfering with device use (e.g., carotid artery coarctation, vasculitis, limited vascular access)
- Contraindications to stenting or required medications, including allergies to contrast media, antiplatelet or anticoagulant drugs, or device materials
- 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
Trial Site Locations
Total: 1 location
1
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
Research Team
H
Huina Lu
CONTACT
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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