Overview

Endovascular Treatment With Versus Without Intravenous Tenecteplase in Stroke

Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this trial is to investigate whether intravenous tenecteplase prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are thrombolysis-eligible within 4.5 hours of symptom onset.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xinqiao Hospital of Chongqing
Collaborators:
Maoming Traditional Chinese Medicine Hospital (Wenguo Huang)
The 904th Hospital of PLA (Zhonghua Shi)
The First Affiliated Hospital of Jilin University (Shouchun Wang)
Wuhan No. 1 Hospital (Wenhua Liu)
Treatments:
Tenecteplase
Criteria
Inclusion Criteria:

1. Aged 18 years or older;

2. Acute ischemic stroke confirmed by clinical symptoms or imaging examination;

3. MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by
CTA/MRA;

4. Eligible for intravenous thrombolysis with TNK-tPA;

5. Time from stroke onset to randomization within 4.25 hours;

6. Written informed consent is obtained from patients and/or their legal representatives.

Exclusion Criteria:

1. CT or MR evidence of intracranial hemorrhage;

2. Contraindications of intravenous thrombolysis;

3. Currently in pregnant or lactating or serum beta HCG test is positive on admission;

4. Contraindication to radiographic contrast agents, nickel, titanium metals or their
alloys;

5. Current participation in another clinical trial

6. Arterial tortuosity and/or other arterial disease that would prevent the device from
reaching the target vessel;

7. Patients with a preexisting neurological or psychiatric disease that would confound
the neurological functional evaluations;

8. Patients with occlusions in multiple vascular territories (e.g. bilateral anterior
circulation, or anterior/posterior circulation);

9. CT or MR evidence of mass effect or intracranial tumor (except small meningioma);

10. CT or MR angiography evidence of intracranial arteriovenous malformations or
aneurysms;

11. Any terminal illness with life expectancy less than 6 months;

12. Unlikely to be available for 90-day follow-up.