Trial Outcomes & Findings for Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial (NCT NCT05172934)

20 MT AIS patients enrolled and treated with IA TNK.

218 MT AI patients assessed for eligibility. Excluded 95 patients with mTICI 3 and 16 patients with mTICI 0, 1, 2a. Excluded 87 patients on demographic and/or other inclusion/exclusion criteria.

Race and Ethnicity were not collected from any participant.

Number of participants with any incidence of intracranial hemorrhage and neurologic worsening of at least 4 points on the National Institute of Health Stroke Scale (NIHSS), according to the European Cooperative Acute Stroke Study II (ECASS-II) criteria, within 24 hours (+/- 8 hours) of treatment with IA TNK. This measure was assessed by imaging (NCCT/MRI) done within this time frame for all the enrolled study participants. This is the primary study-specific baseline measure for the ALLY study.

Ordinal modified Rankin Scale Score at 90 days (+/- 30 days). The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6). This assessment was assessed by the study site personnel. The mRS score could have been obtained over the phone via a structured questionnaire if all attempts to perform as in-person assessment had failed.

Final revascularization grade at end of IA treatment using the modified Thrombolysis in Cerebral Infarction (mTICI) scale. mTICI of grade 3: complete anterograde perfusion with normal filling of all distal branches. mTICI 2c is: Near complete anterograde perfusion to the tissue distal to the baseline occlusion but \< 100% (slow flow in a few distal cortical vessels or presence of small distal cortical emboli). mTICI 2b is: Anterograde Perfusion to the tissue distal to the baseline occlusion but ≥ 50% of the target ischemic territory. The first bolus of intra-arterial TNK was given as soon as possible after mechanical thrombectomy. A dose of 1.5 mL (1 mg/mL) was infused over 1 minute. After 5 minutes, reperfusion was assessed. If TICI 3 was not achieved, a second 1.5 mg bolus was given, followed by another 5-minute assessment. If needed, a third 1.5 mg bolus was given in the same way. After the final 5-minute wait, the final mTICI score was recorded.

Number of participants with any incidence of asymptomatic intracranial hemorrhage. This was assessed by the imaging done at 24 hours from the time of treatment. Both NCCT or MRI were acceptable but MRI was preferred.

Number of boluses given to achieve improvement in reperfusion to mTICI 2c and mTICI 3. This was assessed post-procedure immediately. The first bolus of intra-arterial (IA) tenecteplase (TNK) was given as soon as possible after the mechanical thrombectomy (MT) procedure was complete. A dose of 1.5 mL IA TNK (1 mg/mL) will be infused over 1 minute. After the infusion was complete, the investigator waited 5 minutes before checking the reperfusion status. If complete reperfusion (TICI 3) was not achieved, a second 1.5 mg bolus was given over 1 minute, followed again by a 5-minute waiting period before reassessment. If TICI 3 reperfusion was still not achieved, a third 1.5 mg bolus was administered over 1 minute. After this infusion, the investigator waited another 5 minutes and then assessed the reperfusion status. The final modified TICI (mTICI) score will be recorded after the last assessment.

This secondary outcome was determined when the participant was discharged, or it was determined on day 6(+/- 1 day).