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

Study Overview
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Brief Summary
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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.

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

Conditions
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Intracranial Aneurysms

Intervention / Treatment
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* Device: Coil system(Ton-bridgeMT)
* Device: Axium Detachable Coil(Medtronic)


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>Coil system(Ton-bridgeMT) | Device: Coil system(Ton-bridgeMT)<br>* 1. It consists of a push system with a development mark, and a Detachable platinum-tungsten alloy coil which is connected to the push system. It can be used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula.<br>|
| Active Comparator: group B<br>Axium Detachable Coil(Medtronic) | Device: Axium Detachable Coil(Medtronic)<br>* 2. It is made up of a push system with a development mark, a platinum-tungsten alloy embolized coil connected to the push system and a manual release device for releasing the coil from the distal end of the push system. It is mainly used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of occlusion | Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100% | 180 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate of occlusion | Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100% | intraoperation | 
| Recurrence rate | 2. Number of patients with recurrent aneurysms/ number of overall patients*100% | 180 day |