Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05119647
Other study ID # ZHTQ2021001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2022
Est. completion date August 2023

Study information

Verified date November 2021
Source Zhuhai Tonbridge Medical Tech. Co., Ltd.
Contact Peiyi Li
Phone 13840536851
Email py.li@ton-bridge.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

The study is conducted in 15 centers all around China, aiming at recruiting 155 patients with acute stroke caused by artery occlusion.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 155
Est. completion date August 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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; - 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 .

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
China Xuanwu hospital Capital Medical University Beijing
China Cangzhou central hospital Cangzhou Hebei
China Hunan Provincial People's Hospital Changsha Hunan
China School of medicine UESTC Chengdu Sichuan
China Ganzhou Municipal Hospital Ganzhou Jiangxi
China The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China The First Affiliated Hospital of USTC Hefei Anhui
China Central Hospital Affiliated to Shangdong First Medical University Jinan Shandong
China First People's Hospital of Jinan Jinan Shandong
China The Second People's Hospital of Liaocheng Liaocheng Shandong
China The Second Nanning People's hospital Nanning Guangxi
China Rizhao central Hospital Rizhao Shandong
China Shanxi Candiovascular hospital Taiyuan Shanxi
China Zhuhai people's hospital Zhuhai Guangdong
China Zigong Third People's Hospital Zigong Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Zhuhai Tonbridge Medical Tech. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Up to 90 days
Secondary Successful recanalization rate within three-times aspiration Successful recanalization is defined as mTICI 2b or 3 evaluated by DSA. Intraoperation
Secondary 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. Intraoperation
Secondary 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. 72 hours / 7 days
Secondary Rate of Modified Rankin Scale(mRS) score less than 3 The mRS score is assessed in 90 days follow-up. 90 days
Secondary Device delivery performance Device delivery performance including transport and pullback performance, which is ranked excellent/good/normal/bad. Intraoperation
Secondary The rate of symptomatic intracranial hemorrhage National Institute of Health stroke scale(NIHSS) increased by at least 4 compared with the baseline. 72 hours
Secondary Death rate Subjects who died from any cause would be counted. Up to 90 days
Secondary The rate of AE The definition of AE(Adverse Event) refers to ISO 14155 Up to 90 days
Secondary The rate of SAE The definition of SAE (Serious Adverse Event) refers to ISO 14155 Up to 90 days
Secondary 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. Up to 90 days
See also
  Status Clinical Trial Phase
Recruiting NCT06113848 - Adjunctive Use of Intra-Arterial TNK and Albumin Following Thrombectomy Phase 3
Completed NCT04069546 - The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency N/A
Active, not recruiting NCT05700097 - Dengzhanxixin Injection for Acute Ischemic Stroke Receiving Reperfusion Therapy Phase 2
Recruiting NCT06058130 - Combination of Antiplatelet and Anticoagulation for AIS Patients Witn Concomitant NVAF and Extracranial/Intracranial Artery Stenosis N/A
Recruiting NCT04415164 - Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke Phase 4
Recruiting NCT05363397 - Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke Phase 2
Completed NCT05429658 - Single Arm Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System N/A
Recruiting NCT05390580 - Neuromodulation Using Vagus Nerve Stimulation Following Ischemic Stroke as Therapeutic Adjunct N/A
Enrolling by invitation NCT05515393 - A Study of XY03-EA Tablets in the Treatment of Acute Ischemic Stroke Phase 2
Active, not recruiting NCT05070260 - ACTISAVE: ACuTe Ischemic Stroke Study Evaluating Glenzocimab Used as Add-on Therapy Versus placEbo Phase 2/Phase 3
Terminated NCT05547412 - Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
Completed NCT03366818 - New Stent Retriever, VERSI System for AIS N/A
Not yet recruiting NCT05293080 - Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE Phase 3
Completed NCT02223273 - Brazilian Intervention to Increase Evidence Usage in Practice - Stroke (BRIDGE-Stroke) N/A
Completed NCT02586233 - Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke Phase 1/Phase 2
Not yet recruiting NCT01594190 - Physical Activity Immediately After Acute Cerebral Ischemia N/A
Terminated NCT01694381 - Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor Early Phase 1
Completed NCT01120301 - Efficacy and Safety Trial of Transcranial Laser Therapy Within 24 Hours From Stroke Onset (NEST-3) Phase 3
Completed NCT00963989 - Imaging Guided Patient Selection for Interventional Revascularization Therapy N/A
Completed NCT01021319 - Identification of Stroke Patients ≤ 3 and ≤ 4.5 Hours of Symptom Onset by Fluid Attenuated Inversion Recovery (FLAIR) Imaging and Diffusion Weighted Imaging (DWI)