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.