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

Launched by MICROPORT NEUROTECH CO., LTD. · Jan 2, 2024

Keywords

ClinConnect Summary

The REBRIDGE trial is studying a new type of stent designed to help treat wide-necked intracranial aneurysms, which are bulges in the blood vessels in the brain. The goal of this trial is to see if this new stent is as safe and effective as currently used devices during a procedure called stent-assisted coiling. About 200 people aged 18 to 80 who have been diagnosed with these types of aneurysms may be eligible to participate. To qualify, participants must have aneurysms that can be treated in a single surgery and understand the purpose of the study.

If you decide to take part in this trial, you will undergo a series of evaluations before and after the stent procedure, including imaging tests to check the condition of your aneurysm. These follow-ups will take place at various points over the course of a year. You will also be closely monitored for any side effects or complications from the treatment. It's important to note that certain conditions, such as having other serious health issues or being pregnant, may exclude you from participating. Overall, this trial aims to improve treatment options for people with intracranial aneurysms while ensuring safety and effectiveness.

Gender

ALL

Eligibility criteria

• 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