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

Part of paid clinical trials in Toledo, Ohio.

Sponsor
ProMedica Health System
Study ID
NCT06949228
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • tenecteplase — DRUG
    Patients treated with standard of care mechanical thrombectomy (MT) that achieved mTICI 2b or higher revascularization. Patients will be randomized into one of two arms: IA TNK or control.

Study Details

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.

Key Dates

Start date
Jul 30, 2025
Status verified
Jan 2026
Primary completion
May 30, 2028
Completion
May 30, 2028

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Primary Efficacy Endpoint- Modified Rankin Scale (mRS) [ Time Frame: 90 days (+/- 30 days) post treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ProMedica Toledo HospitalToledoOhio43606-

Find similar trials in Toledo, OH

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
ProMedica Toledo Hospital· Toledo, OH

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