A Single-arm Trial of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

Launched by ZHUHAI TONBRIDGE MEDICAL TECH. CO., LTD. · Jun 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a device called the Flow Diverter (Tonbridge) to see how well it works and how safe it is for treating a specific type of brain condition known as an intracranial aneurysm. An intracranial aneurysm is a bulge in a blood vessel in the brain that has not yet burst. The trial is looking for adult participants, aged 18 to 80, who have one unruptured aneurysm that meets certain size and location criteria.

To be eligible for this study, participants need to have an aneurysm that is less than 10 millimeters in diameter and located in specific arteries in the brain. They also must not have any serious health issues that could complicate the procedure, like recent bleeding in the brain or significant heart or lung problems. Participants will receive the Flow Diverter as part of the treatment and will help researchers learn more about its effectiveness and safety. It’s important for anyone considering participation to understand the study's purpose and to feel comfortable discussing any questions or concerns with their doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 to 80 years, any gender;
• • A single unruptured intracranial aneurysm locates in the intracranial segment of internal carotid artery (ICA) or vertebral artery (VA), which diagnosed by DSA;
• • The maximal diameter of the target aneurysm \< 10 mm diagnosed by DSA;
• • The target aneurysm with a neck ≥ 4 mm or a dome to neck ratio \< 2 diagnosed by DSA;
• • The target aneurysm with a parent vessel diameter of 2.0-6.5 mm;
• • Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
• Exclusion Criteria:
• • Diagnosed as with cerebrovascular malformations;
• • Intracranial hemorrhage within 30 days pre-procedure;
• • Modified Rankin Scale (mRS) score ≥ 3 in pre-procedure;
• • Platelet (PLT) \< 60×10\^9/L or known platelet dysfunction or International Normalized Ratio (INR) \> 1.5;
• • Heart, lung, liver and renal failure or other severe diseases (such as intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery);
• • Subject who is not appropriate for flow diverter delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
• • Major surgery within 30 days before enrollment, or intending to receive surgery within 180 days after enrollment;
• • Allergic history of anesthetics and contrast agents, or contraindication for dual antiplatelet or/and anticoagulant therapy;
• • Allergic history of metals such as nickel-titanium alloy;
• • Life expectancy \< 12 months;
• • Pregnant or breastfeeding women;
• • Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent;
• • Other conditions judged by the investigators as unsuitable for enrollment.