Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorProMedica Health System
About this trial
The study objective is to evaluate the safety and efficacy of Intra arterial (IA) Tenecteplase (TNK) as an adjunctive therapy in acute ischemic stroke (AIS) patients with large vessel occlusions (LVO) in the anterior circulation of Internal Carotid Artery (ICA), Middle Cerebral Arteries (M1 and M2) who achieve a reperfusion grade of Modified Treatment in Cerebral Ischemia Scale (mTICI) 2b or higher post-mechanical thrombectomy using Food and Drug Administration (FDA) approved devices.
Eligibility criteria
Qualifiers
Age 18-85
Anterior circulation ischemic stroke symptoms with confirmed occlusion (ICA, M1, or M2) on angiogram and mechanical thrombectomy initiated within 24 hours since last known well
Alberta Stroke Program Early CT Score (ASPECTS) Score ≥6 on baseline Non-contrast Head CT (NCCT)
Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or higher.
Disqualifiers
Premorbid modified Rankin scale (mRS) score >1
Imaging evidence of hemorrhage or mass effect at baseline
Platelet count <100,000
Active hemorrhagic diathesis, or known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
Trial design
Treatments tested in this trial
- tenecteplase
Treatment groups
132 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov