Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy (ALLY) II Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

• Ability to obtain signed informed consent prior to randomization from LAR or Subject

Locations
United States
Ohio
ProMedica Toledo Hospital
RECRUITING
Toledo
Contact Information
Primary
Syed Fazal Zaidi, MD
Syed.Zaidi2@utoledo.edu
(419)- 291-8027
Backup
Tanya Siddiqui
4192913498
Time Frame
Start Date: 2025-07-30
Estimated Completion Date: 2028-05-30
Participants
Target number of participants: 132
Treatments
Experimental: Randomized to Intra Arterial (IA) Tenecteplase (TNK)
Patients will receive IA- TNK
No_intervention: Randomized to best medical practice
Patients will receive best medical practice treatment
Related Therapeutic Areas
Sponsors
Leads: ProMedica Health System

This content was sourced from clinicaltrials.gov