Intracranial AneurysmsNCT03550638
Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms
A study testing Coil system(Ton-bridgeMT) and Axium Detachable Coil(Medtronic) in people with Intracranial Aneurysms, run by Ton-Bridge Medical Tech. Co., Ltd at 12 sites in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracranial Aneurysms
- What is being tested?
- Coil system(Ton-bridgeMT) and Axium Detachable Coil(Medtronic)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 12 sitesChina
- Study dates
- 28 May 2018to 2 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 .
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
The first hospital of Jilin University
Changchun, Jilin
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
The Second Affiliated hospital of Zhejiang University School of Medicine
Hanzhou
Jiangsu Province Hospital
Nanjin, Jiangsu
Nanjing Brain Hospital
Nanjing, Jiangsu
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality
First Affiliated Hospital of China Medical University
Shenyang, Liaoning
Shengjing Hospital affiliated to China Medical University
Shenyang, Liaoning
Tangdu Hospital of The Fourth Military Medical University
Xi’an, Shanxi
Yantai Yuhuangding Hospital
Yantai, Shandong
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Zhongshan People's Hospital
Zhongshan, Guangdong
About this study
Official title: 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.
- Conditions
- Intracranial Aneurysms
- Being tested
- Coil system(Ton-bridgeMT), Axium Detachable Coil(Medtronic)
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Coil system(Ton-bridgeMT) Receives: Device: Coil system(Ton-bridgeMT) |
| group B | Active comparator | Axium Detachable Coil(Medtronic) Receives: Device: Axium Detachable Coil(Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of occlusion
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%
Measured: 180 day
Secondary outcomes (2)
success rate of occlusion
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%
Measured: intraoperation
Recurrence rate
- Number of patients with recurrent aneurysms/ number of overall patients*100%
Measured: 180 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start28 May 2018
- Primary completion3 Jan 2020
- Study completion2 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ton-Bridge Medical Tech. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianmin Liu, Principal investigator, Changhai Hospital of Shangha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550638
- Sponsor's protocol ID
- ZHTQ2017001
- Status last verified
- Apr 2021
- First submitted
- 28 May 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety Study on Endovascular Embolization of Intracranial Aneurysms With Coil System(Ton-bridgeMT)
- ClinicalTrials.gov ID
- NCT03550638
- Acronym / sponsor ID
- ZHTQ2017001
- Conditions
- Intracranial Aneurysms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Ton-Bridge Medical Tech. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 May 2018 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 8 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: Coil system(Ton-bridgeMT)Coil system(Ton-bridgeMT) |
| group B | Active comparator | Device: Axium Detachable Coil(Medtronic)Axium Detachable Coil(Medtronic) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | group A |
| 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. | Device | group B |
Primary outcome
success rate of occlusion
Time frame: 180 day
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100%
2 secondary outcomes
success rate of occlusion
Time frame: intraoperation
Recurrence rate
Time frame: 180 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianmin Liu principal investigator
Changhai Hospital of Shangha
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coil system(Ton-bridgeMT) and Axium Detachable Coil(Medtronic) in people with Intracranial Aneurysms, run by Ton-Bridge Medical Tech. Co., Ltd at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of occlusion (time frame: 180 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.