Using a new stent to treat wide-necked brain aneurysms

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

This study is testing a new type of stent to see if it works as well as current options for treating wide-necked brain aneurysms in about 200 participants.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: MicroPort NeuroTech Co., Ltd. (industry)
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06189950 on ClinicalTrials.gov

What this trial studies

This trial is a multicenter, open-label, randomized controlled trial designed to evaluate the safety and efficacy of a new intracranial stent for treating wide-necked intracranial aneurysms. Approximately 200 participants will undergo stent-assisted coiling embolization, with evaluations conducted at multiple time points including preoperatively, at discharge, and at 1, 6, and 12 months postoperatively. The study will compare the new stent device against established devices to determine non-inferiority in outcomes. Participants will also undergo imaging assessments to monitor the status of their aneurysms throughout the study.

Who should consider this trial

Good fit: Ideal candidates are males or non-pregnant females aged 18 to 80 with diagnosed wide-necked saccular intracranial aneurysms suitable for stent-assisted coiling.

Not a fit: Patients with aneurysms unsuitable for stent-assisted coiling or with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with wide-necked intracranial aneurysms.

How similar studies have performed: Other studies have shown success with stent-assisted coiling for intracranial aneurysms, indicating that this approach is not entirely novel but aims to improve existing methods.

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

Where this trial is running

Zhengzhou, Henan

• First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)

Study contacts

• Principal investigator: sheng guan — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Huina Lu

Conditions: Brain Diseases, Aneurysm, Intracranial Aneurysm