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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2020-09-02

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.

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Detailed Description

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Conditions

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Intracranial Aneurysms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

Coil system(Ton-bridgeMT)

Group Type EXPERIMENTAL

Coil system(Ton-bridgeMT)

Intervention Type DEVICE

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.

group B

Axium Detachable Coil(Medtronic)

Group Type ACTIVE_COMPARATOR

Axium Detachable Coil(Medtronic)

Intervention Type DEVICE

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.

Interventions

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Coil system(Ton-bridgeMT)

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.

Intervention Type DEVICE

Axium Detachable Coil(Medtronic)

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.

Intervention Type DEVICE

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 .

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No