Intra-arterial t-PA infusion during mechanical thrombectomy in acute ischemic stroke: a randomized trial

Phase 1

• Conditions: People with acute ischemic stroke (AIS) due to large vessel occlusion of the anterior circulation.; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-510374-13-00
• Lead Sponsor: Vall D'hebron Institut De Recerca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Informed consent as documented by signature. It could be also an oral consent and subsequently signed., Patients admitted from a Secondary Stroke Center (SSC) eligible for EVT may be included in the VANISH protocol, if tPA infusion ended 40 minutes before a CT control, confirming the EVT indication, Age =18, Neurological deficit with a NIHSS of =6, Pre-treatment mRs =1, Patients eligible for endovascular treatment, For IVT: Patient within 9 hours of stroke onset according to locally accepted guidelines. Patients with a wake up stroke, may be included if other inclusion criteria are satisfied. The ‘wake up’ stroke is defined as having no symptoms at sleep onset, but stroke symptoms on waking. The time of stroke onset is to be taken as the mid-point between sleep onset (or last known to be normal) and time of waking. The maximum time window for randomization is then 9 hours from the mid-point as described., Occlusion (TICI 0-1) of the intracranial internal carotid artery (ICA) and the M1 segments of the middle cerebral artery (MCA) confirmed by CT or MR angiography, accessible for MT, An ischemic core lesion volume = 70 ml using MR-DWI or CT-CBF, A penumbral mismatch: a hypo-perfusion to core” volume ratio of greater than 1.2 and an absolute difference greater than 10mL (using a MR or CT Tmax > 6 second delay) between perfusion lesion and MR-Diffusion Weighted Imaging (DWI) or CT- Cerebral Blood Flow (CBF) core lesion.

Exclusion Criteria

Any absolute contraindication for IV or IA t-PA, Radiological confirmed evidence of mass effect or intracranial tumor (except small meningioma), Radiological confirmed evidence of cerebral vasculitis, CTA or MRA evidence of tandem occlusions of any cause, Pregnancy or lactating women. A negative pregnancy test before randomization is required for all women with child-bearing potential., Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals, or their alloys, Known renal disease, Severe comorbid condition with life expectancy less than 90 days at baseline, Known advanced dementia or significant pre-stroke disability (mRS=2), Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad), Comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments, Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than four alcoholic drinks per day).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified