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Ischemic StrokeNCT03210623

Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)

A study testing stent retriever(TonbridgeMT) and Solitaire™ in people with Ischemic Stroke, run by Ton-Bridge Medical Tech. Co., Ltd at 17 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is a prospective, multi-center, stratified randomized, single-blind, parallel assignment, active control, non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(TonbridgeMT) or Solitaire™ for endovascular therapy for AIS. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ischemic Stroke
What is being tested?
stent retriever(TonbridgeMT) and Solitaire™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
17 sitesChina
Study dates
3 Aug 2017to 27 Aug 2018
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

  • 18≤ages≤80;
  • Baseline NIHSS score obtained prior to randomization must be lower than 30 points;
  • Acute occlusion(TICI 0-1) of the intracranial segment of internal carotid artery(ICA), or M1/M2 middle cerebral artery(MCA), or A1/A2 anterior cerebral artery(ACA), as evidenced by digital subtraction angiography(DSA);
  • Patient treatable within 6 hours of symptom onset(symptoms onset is defined as point in time the patient was last seen well (at baseline)) can accept the complete femoral artery puncture;
  • Pre-AIS mRS score lower than 2.

Who cannot join

  • Computed tomography (CT) or magnetic resonance imaging (MRI) evidence of intracranial hemorrhage or massive cerebral infarction (ASPECTS score of<6 or infarct volume≥70ml or volume>1/3 blood supplying areas of MCA on CT/diffusion weighted imaging(DWI);
  • DSA evidence of simultaneous acute bilateral carotid occlusion;
  • DSA evidence of occlusions in the initial segment of carotid artery or carotid artery dissection or arteritis;
  • DSA evidence of tortuosity of cervical vessels precluding device delivery/deployment;
  • Hypertension (Systolic blood pressure(SBP)>185 mm Hg or diastolic blood pressure(DBP)>110 mm Hg) after using drug;
  • Platelet count<40,000/μL and use of Novel Anticoagulant with International Normalized Ratio(INR)>3.0;
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  • Random blood glucose of<2.7mmol/L or>22.2mmol/L;
  • Patients with heart or lung or liver or renal failure or other sever disease(intracranial tumors, cerebral arteriovenous malformation (AVM), systemic infection, active disseminated intravascular coagulation, myocardial infarction within the past 12 months before enrollment, history of sever psychosis);
  • Patients who will not cooperate or tolerate interventional operation;
  • Anticipated life expectancy of less than 90 days;
  • Allergy to contrast medium;
  • Females who are pregnant or breastfeeding;
  • Participation in any other clinical trial within the past 1 months before screening and follow-up;
  • The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form;
  • Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence as per investigator's judgement.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • The 306th Hospital of Chinese PLA

    Beijing

  • China-Japan union hospital

    Changchun

  • The First Hospital of Jilin University

    Changchun

  • The First People's Hospital of Changzhou

    Changzhou

  • The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang

  • Hangzhou First People's Hospital

    Hangzhou

  • The Second Affiliated hospital of Zhejiang University School of Medicine

    Hanzhou

  • Nanjing First Hospital Affiliated to Nanjing Medicine University

    Nanjing

  • Nanning People's Hospital

    Nanning

  • Changhai Hospital of Shanghai

    Shanghai, Shanghai Municipality

  • The Third People's Hospital of Hubei Province

    Wuhan

  • Tangdu Hospital

    Xi'an

  • Henan Provincial People's Hospital

    Zhengzhou

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Zhongshan People's Hospital

    Zhongshan

  • The Fifth Affiliated Hospital Sun Yat-sen University

    Zhuhai

Other trials in China

About this study

Official title: The Efficacy and Safety Study of Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke

The study is a prospective, multi-center, stratified randomized, single-blind, parallel assignment, active control, non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(TonbridgeMT) or Solitaire™ for endovascular therapy for AIS. The study aims to evaluate the benefit and safety of stent retriever(TonbridgeMT) for AIS therapy, as compared to Solitaire™.

Read the detailed description

The main objective is to determine whether stent retriever(TonbridgeMT) will have non-inferior successful recanalization rate compared to Solitaire™ when applied to endovascular therapy for AIS.

The secondary objectives is to verify whether there isn't significant differences in time to achieve recanalization, NIHSS score, mRS score, and transportation performance between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.

The third objectives is to verify whether there isn't significant differences in the rate of symptomatic intracranial hemorrhage, subarachnoid hemorrhage, adverse event(AE), serious adverse event(SAE), actual condition of AE and device deficiencies between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.

Conditions
Ischemic Stroke
Being tested
stent retriever(TonbridgeMT), Solitaire™
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stent retriever(TonbridgeMT)Device

    mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)

  • Solitaire™Device

    mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)

Study groups in NCT03210623
Study groupRoleWhat they receive
group AExperimentalsubjects applying the stent retriever(TonbridgeMT)
Receives: Device: stent retriever(TonbridgeMT)
group BActive comparatorsubjects applying Solitaire™
Receives: Device: Solitaire™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. successful recanalization rate in patients

    Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA intraoperative immediately in both treatment groups

    Measured: intraoperative immediate

Secondary outcomes (6)

  1. successful recanalization rate in vessels

    The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment

    Measured: intraoperative immediate

  2. Time to achieve recanalization

    The period from femoral artery puncture to successful recanalization

    Measured: intraoperative immediate

  3. NIHSS score

    National Institutes of Health Stroke Scale

    Measured: baseline, 24±6d and 7±2d after operation

  4. mRS score

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.

    Measured: baseline, 90±14d after operation

  5. the ratio of mRS 0-2

    The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment

    Measured: baseline, 90±14d after operation

  6. transportation performance

    The proportion of stent retriever which can push and draw back well during the operation. The operator will grade each stent retriever at four level, namely great， good， average，and bad

    Measured: intraoperative immediate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2017
  2. Study start3 Aug 2017
  3. Primary completion27 Aug 2018
  4. Study completion27 Aug 2018

Resources

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
Model description
prospective, stratified-randomized, single-blind, parallel assignment, active control
Masking
Single blind
Who is masked
Participant
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03210623
Sponsor's protocol ID
JCQ-B-010
Status last verified
Jun 2017
First submitted
2 Jul 2017
Last updated
12 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Y, Hua W, Li Z, Peng Y, Han Z, Li T, Yin C, Wang S, Nan G, Zhao Z, Yang H, Zhou B, Li T, Cai Y, Zhang J, Li G, Peng X, Guan S, Zhou J, Ye M, Wang L, Zhang L, Hong B, Zhang Y, Wan J, Wang Y, Zhu Q, Liu J, Yang P. Efficacy and Safety of a Novel Thrombectomy Device in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial. Front Neurol. 2021 Aug 12;12:686253. doi: 10.3389/fneur.2021.686253. eCollection 2021.

    PubMed 34456847

Questions about this trial

What is this clinical trial studying?

A study testing stent retriever(TonbridgeMT) and Solitaire™ in people with Ischemic Stroke, run by Ton-Bridge Medical Tech. Co., Ltd at 17 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 5 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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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 in patients (time frame: intraoperative immediate). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03210623, which also lists 1 linked publication.

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 12 Sep 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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