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Completed

NCT Number: NCT03550638

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhongshan People's Hospital, Zhongshan, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Coil system(Ton-bridgeMT)

Device
  • 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.

Axium Detachable Coil(Medtronic)

Device
  • 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.

Primary outcomes

  1. success rate of occlusion

    Time frame: 180 day

    Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%

Secondary outcomes

  1. success rate of occlusion

    Time frame: intraoperation

    Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%

  2. Recurrence rate

    Time frame: 180 day

    • Number of patients with recurrent aneurysms/ number of overall patients*100%

Sponsors and collaborators

Lead sponsor

Ton-Bridge Medical Tech. Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 8, 2018
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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