Status:
COMPLETED
Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke
Lead Sponsor:
Xinqiao Hospital of Chongqing
Collaborating Sponsors:
CSPC RECOMGEN PHARMACEUTICAL (GUANGZHOU) CO.,LTD
Conditions:
Stroke, Acute
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this trial is to investigate whether intravenous rhTNK-tPA prior to endovascular treatment can improve 90-day functional outcome of stroke patients with large vessel occlusion who are t...
Detailed Description
The DEVT, SKIP and DIRECT-MT trials showed that endovascular treatment alone is not inferior to intravenous alteplase bridging with endovascular treatment in terms of achieving 90-day functional indep...
Eligibility Criteria
Inclusion
- Aged 18 years or older;
- Patient with acute ischemic stroke who is eligible for intravenous thrombolysis treatment within 4.5 hours of time last known well;
- No significant prestroke functional disability: for age \<80 years, prestroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1;
- MCA-M1 or -M2, basilar artery, or posterior cerebral artery-P1 occlusion proved by CTA/MRA;
- EVT is planned by clinical care team;
- Written informed consent is obtained from patients and/or their legal representatives.
Exclusion
- Intracranial hemorrhage on baseline CT or MR
- Contraindication to intravenous thrombolytics
- Already received intravenous thrombolytic after index stroke
- Known pregnancy, or breastfeeding, or serum beta human chorionic gonadotropin test is positive on admission
- Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys
- Current participation in another investigational drug clinical trial
- Arterial tortuosity and/or other arterial disease that would lead to unstable access platform or prevent the thrombectomy device from reaching the target vessel
- Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments
- Patient with occlusions in two or more vascular territories (e.g. bilateral territories, or anterior and posterior circulation)
- Mass effect or intracranial neoplasm on baseline CT or MR (except small meningioma)
- Intracranial arteriovenous malformation or aneurysm on baseline CT or MR angiography
- Any terminal disease with a life expectancy less than half a year
- Unlikely to be available for follow-up at 90 days.
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2025
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT04733742
Start Date
May 9 2022
End Date
February 7 2025
Last Update
April 3 2025
Active Locations (6)
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1
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, China, 400037
2
The Second Hospital of Jiaozuo
Jiaozuo, Henan, China
3
Wuhan No. 1 Hospital
Wuhan, Hubei, China, 430000
4
The First Affiliated Hospital, Hengyang Medical School, University of South China
Hengyang, Hunan, China