Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07047014

Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke

Led by Beijing Tiantan Hospital · Updated on 2026-04-01

596

Participants Needed

7

Research Sites

100 weeks

Total Duration

On this page

Sponsors

B

Beijing Tiantan Hospital

Lead Sponsor

F

First Affiliated Hospital of Zhejiang University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Results from recent several trials provided data showing limits to the effectiveness of thrombectomy for ischemic stroke due to medium vessel occlusions.The benefit-risk profile of thrombolysis for these patients has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of tenecteplase (0.25mg/kg, maximum dose 25mg) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 4.5 to 24 hours from symptom onset.

CONDITIONS

Official Title

Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ischemic Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute ischemic stroke symptom onset within 4.5 to 24 hours, including wake-up and unwitnessed strokes
  • Primary medium vessel occlusions confirmed by CTA or MRA in specific brain artery segments causing stroke symptoms
  • Neuroimaging showing target mismatch profile on CT perfusion or MRI+MR perfusion, or ASPECTS/PC-ASPECTS score of 8 or more if perfusion imaging is unavailable
  • Pre-stroke modified Rankin scale score 1 or less
  • Baseline National Institutes of Health Stroke Scale (NIHSS) score 6 or higher, or 3 to 5 with disabling symptoms
  • Written informed consent from patients or their legally authorized representatives
Not Eligible

You will not qualify if you...

  • Allergy to tenecteplase
  • Rapidly improving symptoms as judged by the investigator
  • NIHSS consciousness score 1a greater than 2, epileptic seizure, Todd's palsy, or other neurological/mental illness preventing cooperation
  • Planned endovascular treatment
  • Persistent high blood pressure (systolic 185 mmHg or higher, or diastolic 110 mmHg or higher) despite treatment
  • Blood glucose below 2.8 or above 22.2 mmol/L
  • Active internal bleeding or high bleeding risk, including recent major surgery, trauma, hemorrhage, or arterial puncture
  • Known coagulation disorders or recent use of anticoagulants without reversal
  • Platelet defects or platelet count below 100,000/mm3 (patients on antiplatelet medication may be included)
  • Recent ischemic stroke, myocardial infarction, intracranial hemorrhage, severe brain injury, or brain surgery within 3 months
  • Terminal illness with expected survival less than 1 year
  • Unable to perform CT perfusion or MR perfusion imaging
  • Hypodensity in more than one-third of the middle cerebral artery territory or evidence of distal clot migration
  • Acute or past intracerebral hemorrhage shown by imaging
  • Pregnancy, nursing, or unwillingness to use effective contraception
  • Unlikely to follow the trial protocol or complete follow-up
  • Participation in other interventional clinical trials within the past 3 months

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 7 locations

1

Beijing tiantan hospital

Beijing, Beijing Municipality, China, 100070

Not Yet Recruiting

2

Jiuquan city people's hospital

Jiuquan, Gansu, China, 736100

Actively Recruiting

3

Xingtang People's Hospital

Shijiazhuang, Hebei, China, 050600

Actively Recruiting

4

Jiyuan Traditional Chinese Medicine Hospital

Jiyuan, Henan, China, 459000

Actively Recruiting

5

The first people hospital of lingbao

Lingbao, Henan, China, 472500

Actively Recruiting

6

Hai'an People's Hospital

Nantong, Jiangsu, China, 226600

Actively Recruiting

7

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310003

Not Yet Recruiting

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Research Team

Y

Yunyun Xiong

CONTACT

Z

Ziqi Xu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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