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Canceled by the investigator. Intravenous Tenecteplase Plus Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: a Multicenter, Double-Blind, Randomized Controlled Trial

Intravenous Tenecteplase Plus Endovascular Treatment Versus Endovascular Treatment Alone For Stroke Patient With Large Vessel Occlusion: a Multicenter, Double-Blind, Randomized Controlled Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042450
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-07-01
Completion date
Unknown
Last updated
2023-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

combination treatment group:Intravenous thrombolysis with tenecteplase combined with endovascular therapy
endovascular treatment group:Endovascular therapy

Sponsors

Xinqiao Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged 18 years or older; 2) Anterior circulation acute ischemic stroke confirmed by clinical symptoms or imaging examination; 3) MCA-M1 or -M2 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

Exclusion criteria: (1) CT or MR evidence of intracranial hemorrhage; (2) Contraindications of intravenous Tenecteplase; (3) Pre-morbidity with a modified Rankin scale score >= 2; (4) Currently in pregnant or lactating or serum beta HCG test is positive on admission; (5) Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys; (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 evidence of cerebral vasculitis; (11) CT or MR angiography evidence of intracranial arteriovenous malformations or aneurysms; (12) Any terminal illness with life expectancy less than 6 months; (13) Unlikely to be available for 90-day follow-up; (14) Current participation in another clinical trial.

Design outcomes

Primary

MeasureTime frame
modified Rankin scale score;

Secondary

MeasureTime frame
Substantial reperfusion at initial angiogram;Revascularization rates at 24 hours from randomization;Improvement in NIHSS between baseline and 24 hours, and 5~7d;Symptomatic/Asymptomatic intracranial hemorrhage within 48 hours;Parenchymal hematoma;Mortality within 90 days;Procedural-related complication and severe adverse events;

Countries

China

Contacts

Public ContactYang Qingwu

Xinqiao Hospital of the Army Medical University

yangqwmlys@163.com+86 13657638868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026