Acute Ischemic StrokeNCT05119647
A Single-Arm Objective Performance Criteria Trial for Intracranial Thrombus Aspiration Catheter
A study testing Thrombus Aspiration Catheter(Ton-bridgeMT) in people with Acute Ischemic Stroke, run by Ton-Bridge Medical Tech. Co., Ltd at 15 sites in China.
Trial summary
This is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Thrombus Aspiration Catheter(Ton-bridgeMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 15 sitesChina
- Study dates
- 11 Feb 2022to 15 Nov 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Baseline NIHSS score ≥6;
- Subject has acute occlusion located in Vertebral artery(VA) / Internal Carotid Artery (ICA) / M1or M2 segment of Middle Cerebral Artery (MCA) / Basilar artery (BA) diagnosed by DSA;
- Femoral artery puncture is expected to be completed within 24 hours of onset；
- mRS score≤ 2;
- Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent.
Who cannot join
- Chronic occlusion in the target area;
- Epilepsy at the time of stroke；
- Bleeding from the gastrointestinal or urinary system in the past three weeks；
- After drug control, systolic blood pressure was greater than 185mmhg and / or diastolic blood pressure was greater than 110mmhg;
- International Normalized Ratio(INR)>3;
- Random blood glucose < 2.7mmol/L or > 22.2mmol/L;
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- Heart, lung, liver, kidney failure or other serious diseases (such as brain tumors, - systemic infection, active disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe mental illness);
- Tortuous lesion / severe stenosis in the starting segment of the carotid artery / Carotid dissection / Arteritis judged by researchers that is not suitable for the procedure;
- Acute occlusion of bilateral carotid arteries；
- Intracranial hemorrhage or massive infarction diagnosed by CT or MR;
- History of allergies to antiplatelet drugs, anticoagulants, anesthetics, contrast agents;
- Expected life <12 months;
- Female subjects who are pregnant or planning to become pregnant or lactate within the study period;
- Subject has participated in any other drug or medical device clinical trials in 1 month before signing informed consent;
- Other circumstances judged by researchers that are not suitable for enrollment .
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Xuanwu hospital Capital Medical University
Beijing
Cangzhou central hospital
Cangzhou, Hebei
Hunan Provincial People's Hospital
Changsha, Hunan
School of medicine UESTC
Chengdu, Sichuan
Ganzhou Municipal Hospital
Ganzhou, Jiangxi
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affiliated Hospital of USTC
Hefei, Anhui
Central Hospital Affiliated to Shangdong First Medical University
Jinan, Shandong
First People's Hospital of Jinan
Jinan, Shandong
The Second People's Hospital of Liaocheng
Liaocheng, Shandong
The Second Nanning People's hospital
Nanning, Guangxi
Rizhao central Hospital
Rizhao, Shandong
Shanxi Candiovascular hospital
Taiyuan, Shanxi
Zhuhai people's hospital
Zhuhai, Guangdong
Zigong Third People's Hospital
Zigong, Sichuan
About this study
Official title: The Efficacy and Safety Study of Thrombus Aspiration Catheter(Ton-bridgeMT) on Endovascular Treatment of Acute Ischemic Stroke
This is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter.
Read the detailed description
The study is conducted in 15 centers all around China, aiming at recruiting 155 patients with acute stroke caused by artery occlusion.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Thrombus Aspiration Catheter(Ton-bridgeMT)
- Keywords
- Stroke, Aspiration, Catheter, Intracranial
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombus Aspiration Catheter(Ton-bridgeMT)Device
Thrombus Aspiration Catheter is a developed technique for treating acute stroke caused by artery occlusion. The catheter(Ton-bridgeMT) was specially designed for those patients who experience acute stroke within 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Aspiration thrombectomy | Experimental | Since this is a single-arm objective performance criteria trial, patients with acute stoke caused by artery occlusion shall not be divided into two groups. Receives: Device: Thrombus Aspiration Catheter(Ton-bridgeMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful recanalization rate within three-times aspiration
Successful recanalization is defined as modified Thrombolysis In Cerebral Infarction scale(mTICI) 2b or 3 evaluated by Digital subtraction angiography (DSA).
Measured: Up to 90 days
Secondary outcomes (10)
Successful recanalization rate within three-times aspiration
Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA.
Measured: Intraoperation
Successful recanalization rate beyond three-times aspiration
Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA. Auxiliary device such as stent could be used.
Measured: Intraoperation
National Institute of Health stroke scale(NIHSS)
NIHSS score in 72 hours and 7 days(or the day when patients discharged, depends on which day is earlier) will be compared.
Measured: 72 hours / 7 days
Rate of Modified Rankin Scale(mRS) score less than 3
The mRS score is assessed in 90 days follow-up.
Measured: 90 days
Device delivery performance
Device delivery performance including transport and pullback performance, which is ranked excellent/good/normal/bad.
Measured: Intraoperation
The rate of symptomatic intracranial hemorrhage
National Institute of Health stroke scale(NIHSS) increased by at least 4 compared with the baseline.
Measured: 72 hours
Death rate
Subjects who died from any cause would be counted.
Measured: Up to 90 days
The rate of AE
The definition of AE(Adverse Event) refers to ISO 14155
Measured: Up to 90 days
The rate of SAE
The definition of SAE (Serious Adverse Event) refers to ISO 14155
Measured: Up to 90 days
The rate of medical device deficiency
Medical device deficiency refer to the unreasonable risks of medical devices that may endanger human health and life safety under normal use in the process of clinical trials, such as label errors, quality problems, malfunctions, etc.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start11 Feb 2022
- Primary completion24 Aug 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ton-Bridge Medical Tech. Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liqun Jiao, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119647
- Sponsor's protocol ID
- ZHTQ2021001
- Status last verified
- Sep 2024
- First submitted
- 3 Nov 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety Study of Thrombus Aspiration Catheter(Ton-bridgeMT) on Endovascular Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05119647
- Acronym / sponsor ID
- ZHTQ2021001
- Conditions
- Acute Ischemic Stroke
- Keywords
- Stroke, Aspiration, Catheter, Intracranial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Ton-Bridge Medical Tech. Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 15 Nov 2021 (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.
This is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter.
Detailed description
The study is conducted in 15 centers all around China, aiming at recruiting 155 patients with acute stroke caused by artery occlusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aspiration thrombectomy | Experimental | Device: Thrombus Aspiration Catheter(Ton-bridgeMT)Since this is a single-arm objective performance criteria trial, patients with acute stoke caused by artery occlusion shall not be divided into two groups. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years;
- Baseline NIHSS score ≥6;
- Subject has acute occlusion located in Vertebral artery(VA) / Internal Carotid Artery (ICA) / M1or M2 segment of Middle Cerebral Artery (MCA) / Basilar artery (BA) diagnosed by DSA;
- Femoral artery puncture is expected to be completed within 24 hours of onset；
- mRS score≤ 2;
Key exclusion criteria (15 listed)
- Chronic occlusion in the target area;
- Epilepsy at the time of stroke；
- Bleeding from the gastrointestinal or urinary system in the past three weeks；
- After drug control, systolic blood pressure was greater than 185mmhg and / or diastolic blood pressure was greater than 110mmhg;
- International Normalized Ratio(INR)>3;
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 |
|---|---|---|
| Thrombus Aspiration Catheter(Ton-bridgeMT)Thrombus Aspiration Catheter is a developed technique for treating acute stroke caused by artery occlusion. The catheter(Ton-bridgeMT) was specially designed for those patients who experience acute stroke within 24 hours. | Device | Aspiration thrombectomy |
Primary outcome
Successful recanalization rate within three-times aspiration
Time frame: Up to 90 days
Successful recanalization is defined as modified Thrombolysis In Cerebral Infarction scale(mTICI) 2b or 3 evaluated by Digital subtraction angiography (DSA).
10 secondary outcomes
Successful recanalization rate within three-times aspiration
Time frame: Intraoperation
Successful recanalization rate beyond three-times aspiration
Time frame: Intraoperation
National Institute of Health stroke scale(NIHSS)
Time frame: 72 hours / 7 days
Rate of Modified Rankin Scale(mRS) score less than 3
Time frame: 90 days
Device delivery performance
Time frame: Intraoperation
The rate of symptomatic intracranial hemorrhage
Time frame: 72 hours
Death rate
Time frame: Up to 90 days
The rate of AE
Time frame: Up to 90 days
The rate of SAE
Time frame: Up to 90 days
The rate of medical device deficiency
Time frame: Up to 90 days
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 19 Sep 2024.
- 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.
Liqun Jiao principal investigator
Xuanwu Hospital, Beijing
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombus Aspiration Catheter(Ton-bridgeMT) in people with Acute Ischemic Stroke, run by Ton-Bridge Medical Tech. Co., Ltd at 15 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 6 inclusion and 15 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Successful recanalization rate within three-times aspiration (time frame: Up to 90 days). 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 19 Sep 2024; AzTrials last refreshed its copy on 6 Nov 2026.