A Single-Arm Objective Performance Criteria Trial for Intracranial Thrombus Aspiration Catheter

NCT05119647 | Completed

• 1 other identifier: ZHTQ2021001
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 15

Brief Summary

This is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Aspiration; Catheter; Intracranial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Successful recanalization rate within three-times aspiration

  Intraoperation

• Successful recanalization rate beyond three-times aspiration

  Intraoperation

• National Institute of Health stroke scale(NIHSS)

  72 hours / 7 days

• Rate of Modified Rankin Scale(mRS) score less than 3

  90 days

• Device delivery performance

  Intraoperation

Study Arms (1)

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.

Device: Thrombus Aspiration Catheter(Ton-bridgeMT)

Interventions

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.

Aspiration thrombectomy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Ton-Bridge Medical Tech. Co., Ltd: lead

Study Sites (15)

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Location

Zhuhai people's hospital

Zhuhai, Guangdong, China

Location

The Second Nanning People's hospital

Nanning, Guangxi, China

Location

Cangzhou central hospital

Cangzhou, Hebei, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, China

Location

Ganzhou Municipal Hospital

Ganzhou, Jiangxi, China

Location

Central Hospital Affiliated to Shangdong First Medical University

Jinan, Shandong, China

Location

First People's Hospital of Jinan

Jinan, Shandong, China

Location

The Second People's Hospital of Liaocheng

Liaocheng, Shandong, China

Location

Rizhao central Hospital

Rizhao, Shandong, China

Location

Shanxi Candiovascular hospital

Taiyuan, Shanxi, China

Location

School of medicine UESTC

Chengdu, Sichuan, China

Location

Zigong Third People's Hospital

Zigong, Sichuan, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Xuanwu hospital Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Liqun Jiao

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 15, 2021
• Study Start: February 11, 2022
• Primary Completion: August 24, 2022
• Study Completion: November 15, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)