Safety and Feasibility of Intravenous Tenecteplase thrombolysis plus Intra-arterial (IA) Tenecteplase thrombolysis in ischaemic stroke patients with medium vessel occlusion (distal M2, 3, 4, ACA, PCA).

orthern Sydney Local Health District0 sites3 target enrollmentJune 7, 2021

ConditionsIschaemic stroke Stroke - Ischaemic

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ischaemic stroke
Sponsor: orthern Sydney Local Health District
Enrollment: 3
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

All three participants received intra-arterial clot-busting medication following intra-venous thrombolysis with clot-busting medication within 4.5 hours of symptom onset. None of the participants had a bleeding complication or allergic reaction. One of the three participants achieved full re-opening of the blocked vessel, but their clinical outcome did not improve after the procedure due to contributing factors including a rare reaction to contrast (not allergic). The other two participants achieved above 90% re-opening of the blocked vessel and had significantly improved clinical outcomes after the procedure (on day 3 after treatment and 3 months later). Both patients could return to work.

Registry

who.int

Start Date

June 7, 2021

End Date

September 8, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

orthern Sydney Local Health District

Eligibility Criteria

Inclusion Criteria

•1\. Patients presenting with acute ischaemic stroke eligible using standard criteria to receive IV thrombolysis within 4\.5 hours of stroke onset.
•2\. Patient’s age is 18 years or over
•3\. Intra\-arterial clot retrieval treatment can commence (arterial puncture) within 6 hours of stroke onset.
•4\. Willing to provide written (or oral) informed consent.
•Imaging inclusion Criteria
•5\. Arterial occlusion on CT\-Angiogram or MR\-Angiogram of distal MCA (middle cerebral artery) branches (M2, 3, 4\), ACA (anterior cerebral artery) or PCA (posterior cerebral artery) or corresponding CT\-perfusion deficit

Exclusion Criteria

•1\. Intracranial haemorrhage (ICH) identified by CT or MRI
•2\. Rapidly improving symptoms at the discretion of the Investigator.
•3\. Pre\-stroke mRS equal to or greater than 4
•4\. Contraindication to imaging with contrast agents
•5\. Any terminal illness such that patient would not be expected to survive more than 1 year.
•6\. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
•7\. Pregnant women.