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

Zhuhai Tonbridge Medical Technology

Status

Completed

Conditions

Intracranial Aneurysms

Treatments

Device: Coil system(Ton-bridgeMT)

Device: Axium Detachable Coil(Medtronic)

Study type

Interventional

Funder types

Industry

Identifiers

NCT03550638

ZHTQ2017001

Details and patient eligibility

About

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.

Enrollment

256 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 .