Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
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
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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