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NOT YET RECRUITING
NCT07469293
PHASE3

Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO)

Sponsor: Southwest Hospital, China

View on ClinicalTrials.gov

Summary

DATE-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of tenecteplase combined with standard medications in acute ischemic stroke patients with medium vessel occlusion stroke within 24 hours of onset.

Official title: Efficacy and Safety of Intra-arterial Tenecteplase in Acute Ischemic Stroke Patients With Medium Vessel Occlusion Stroke (DATE-MeVO): A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

488

Start Date

2026-03-25

Completion Date

2028-12-31

Last Updated

2026-03-20

Healthy Volunteers

No

Interventions

PROCEDURE

Intra-arterial thrombolysis

A standardized microcatheter-based technique was used to administer recombinant TNK-tPA directly into the thrombus. The total dose (0.0625 mg/kg, max 6.25 mg) was delivered in three equal parts: distally, within the mid-clot, and proximally. Angiographic reassessment at 5 minutes determined if a second identical dose was required (max cumulative dose: 0.125 mg/kg). The procedure was continuously monitored and could be terminated immediately for safety concerns.

OTHER

Standard medical treatment

Standard medical treatment

Locations (45)

Affiliated Hospital of Youjiang Medical University for Nationalities

Baise City, Guangxi, China

Guilin People'S Hospital

Guilin, Guangxi, China

The People's Hospital Of QianNan

Qiannan, Guizhou, China

Chongzhou People's Hospital

Chengdu, Sichuan, China

Dali Nationality Autonomous Prefecture Hospital

Dali, Yunnan, China

Qujing Central Hospital of Yunnan Province

Qujing, Yunnan, China

Ankang Central Hospital

Ankang, China

The People'S Hospital of Anyang City

Anyang, China

Changchun Central Hospital

Changchun, China

Chengdu Second People's Hospital

Chengdu, China

Chonggang General Hospital

Chongqing, China

Chongqing University Fuling Hospital

Chongqing, China

Jiangjin Central Hospital

Chongqing, China

The Ninth People'S Hospital of Chongqing

Chongqing, China

The Thrid Affiliated Hospital of CQMU

Chongqing, China

Yunyang County People'S Hospital

Chongqing, China

The First Affiliated Hospital of Fujian Medicaluniversity

Fuzhou, China

Guangyuan Central Hospital

Guangyuan, China

Qiandongnan Prefecture People's Hospital

Guizhou, China

Huaibei Miners General Hospital

Huaibei, China

The People's Hospital of Jianyang City

Jianyang, China

The 960th Hospital of the PLA Joint Logistics Support Force

Jinan, China

Luoyang Mengjin People's Hospital

Luoyang, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Yiyang County People'S Hospital

Luoyang, China

The Affiliated Hospital of Southwest Medical University

Luzhou, China

The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University

Luzhou, China

Mianyang 404 Hospital

Mianyang, China

Mudanjiang First People's Hospital

Mudanjiang, China

The First People's Hospital of Qingzhen

Qingzhen, China

Yellow River Sanmenxia Hospital

Sanmenxia, China

Ninglin People's Hospital

Shangqiu, China

The First People'S Hospital of Shangqiu

Shangqiu, China

The People's Hospital Of An Jv

Suining, China

Yutian Hospital

Tangshan, China

Wuhan Puren Hospital

Wuhan, China

Zhongnan Hospital of Wuhan University

Wuhan, China

Xiangyang No.1 People's Hospital

Xiangyang, China

Yaan People's Hospital

Ya'an, China

Yichang Central People's Hospital

Yichang, China

Zhengzhou Central Hospital

Zhengzhou, China

Zhoukou Central Hospital

Zhoukou, China

Zhumadian Central Hospital

Zhumadian, China

Zhuzhou Central Hospital

Zhuzhou, China

Zigong Third People's Hospital

Zigong, China