Prospective, single center, non-randomized, pilot study to assess the feasibility of IA TNK following standard of care mechanical thrombectomy (MT) in patients with AIS. Participants will receive IA TNK after achieving mTICI 2b or 2c reperfusion with standard of care MT. Patients enrolled into the study will be followed for 3 months after treatment with IA TNK.
As current MT technology is not amenable to retrieval of distal occlusions (M3/M4, etc), we hypothesize that IA lytic may play an important role as an adjunctive therapy to open up distal vessels (after the primary LVO has been removed) to achieve complete or near complete reperfusion. In this pilot trial, our goal is to assess the feasibility and safety of IA Tenecteplase (TNK) as an adjunctive therapy following standard of care mechanical thrombectomy (MT) in patients with AIS. A total of 20 patients will be enrolled into the ALLY pilot study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
intra-arterial drug administered after mechanical thrombectomy
ProMedica Toledo Hospital
Toledo, Ohio, United States
Incidence of any intracranial hemorrhage and neurologic worsening
Incidence of any 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 of treatment with IA TNK
Time frame: 24 hours post-treatment with intra-arterial Tenecteplase
Improved reperfusion
Proportion of patients with improved reperfusion (mTICI 2c/3) at end of IA treatment
Time frame: immediate post-treatment
Improved reperfusion
Proportion of patients with improvement of reperfusion to mTICI 2c, mTICI 3, and mTICI 2c-3.
Time frame: immediate post-treatment
Ordinal modified Rankin Scale Score
Ordinal modified Rankin Scale Score at 90 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).
Time frame: 90 days post-treatment
Functional Independence
Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days
Time frame: 90 days post-treatment
Final revascularization grade
Final revascularization grade at end of IA treatment using the modified Thrombolysis in Cerebral Infarction (mTICI) grading scale.
Time frame: immediate post-treatment
Mortality
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Mortality rate at discharge
Time frame: Hospital Discharge (Day 6 post-randomization (+/- 1 day))
Asymptomatic intracranial hemorrhage
Incidence of any asymptomatic intracranial hemorrhage
Time frame: 24 hours post-treatment
Mean number of boluses
Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3
Time frame: Immediate post-procedure