Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms

The Efficacy and Safety Study on Endovascular Embolization of Intracranial Aneurysms With Coil System(Ton-bridgeMT)

The study is a prospective, multi-center, randomized, open, parallel positive control, non-inferiority trial. Patients are randomized 1:1 to either Coil System(Ton-bridgeMT) or Axium Detachable Coil(Medtronic).

The purpose of this study is to assess the safety and effectiveness of the Coil System(Ton-bridgeMT) in the treatment of intracranial aneurysms.

Inclusion Criteria:

• Age 18-80 years.
• Subject has a target intracranial aneurysm (IA) diagnosed by DSA, and intended to be embolised with coil system.
• Subject or guardian is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent.

Exclusion Criteria:

• Subject is diagnosed as multiple aneurysms.
• Subject is diagnosed as intracranial bulloid, fusiform, false, dissectimng, infective aneurysm or with arteriovenous malformation.
• mRS score≥3.
• Hunt and Hess classification≥4.
• Subject has emergency ruptured aneurysms and needs assisting stent.
• The target aneurysm has received endovascular embolization or surgical treatment.
• The aneurysm carrier artery has severe stenosis.
• PLT<60×109/L or INR>1.5.
• Subject has nonfunction of important organs or other severe diseases.
• Major surgery in the last 30 days, or intending to receive surgical treatment in 90 days after enrollment.
• Subject is allergic to antiplatelet drugs, anticoagulants, anesthetics, contrast agents or any related contraindication.
• History of allergies to platinum and tungsten.
• Expected life <12 months.
• Pregnant or lactating women.
• Subject has participated in any other drug or medical device clinical trials in 1 month before writting informed consent .
• Other circumstances judged by researchers are not suitable for enrollment .