Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Intra-arterial Tenecteplase · 1 trial · 1 indication
Number of participants with symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage) producing decline from the initial National Institutes of Health Stroke Scale (NIHSS) of ≥ 4 points.
Number of participants with parenchymal hematoma type 1
Number of participants with parenchymal hematoma type 2
Number of patients expired
Number of patients expired
Total number of grade 3 adverse events
| Arm | Type | Description |
|---|---|---|
| Intra-arterial Tenecteplase | EXPERIMENTAL | Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of intra-arterial Tenecteplase (0.125 mg/kg, maximum dose 12.5 mg) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist. |
| Intra-arterial Saline | PLACEBO_COMPARATOR | Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of saline (0.9% NaCl solution) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist. |
| Name | Type | Description |
|---|---|---|
| Intra-arterial Tenecteplase | DRUG | One-time dose of intra-arterial tenecteplase post-thrombectomy |
| Intra-arterial Saline | DRUG | One-time dose of intra-arterial saline post-thrombectomy |
Inclusion Criteria: * Patient/legally authorized representative has signed the Informed Consent Form * Ability to comply with the study protocol, in the investigator's judgment * Functionally independent (modified Rankin scale 0-2) prior to presentation * Baseline National Institutes of Health Stro...