Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 85Years
All Genders
NCT06949228

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

Led by ProMedica Health System · Updated on 2026-01-21

132

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 85 years
  • Acute ischemic stroke symptoms in the anterior circulation with confirmed occlusion in ICA, M1, or M2
  • Mechanical thrombectomy started within 24 hours since last known well
  • Alberta Stroke Program Early CT Score (ASPECTS) of 6 or higher on baseline CT
  • Achieved mTICI grade 2b or higher after mechanical thrombectomy with 5 or fewer device passes
  • Ability to provide signed informed consent prior to randomization from legally authorized representative or subject
Not Eligible

You will not qualify if you...

  • Premorbid modified Rankin scale (mRS) score greater than 1
  • Imaging shows hemorrhage or mass effect at baseline
  • Platelet count less than 100,000
  • Active hemorrhagic or coagulation disorders
  • Use of novel oral anticoagulants within last 48 hours or INR above 1.7
  • Need for dual antiplatelet treatment (e.g., carotid artery stenting)
  • Pregnant or lactating
  • Known allergy to Tenecteplase
  • Major surgery within past 30 days
  • On or requiring dialysis
  • History of intracranial hemorrhage or serious head trauma at any time
  • Any condition that would prevent participation as judged by physician
  • Pre-existing medical, neurological, or psychiatric disease affecting evaluation
  • Severe uncontrolled hypertension resistant to treatment
  • Acute ischemic stroke in last 60 days or thrombolytic treatment in last 90 days
  • Suspected septic embolus or bacterial endocarditis
  • Suspected aortic dissection
  • Intracranial tumor
  • Terminal illness with life expectancy less than 6 months
  • Concurrent enrollment in conflicting clinical trial
  • Unlikely to return for 90-day follow-up
  • Concurrent treatment with intravenous tissue plasminogen activator (tPA)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

ProMedica Toledo Hospital

Toledo, Ohio, United States, 43606

Actively Recruiting

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Research Team

S

Syed Fazal Zaidi, MD

CONTACT

T

Tanya Siddiqui

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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