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Completed

NCT Number: NCT05172934

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age 18-85
  • 2. 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
  • 3. a. Patients treated less than 6 hours since last known well with ASPECTS >6. b. Patients treated beyond 6 hours since last known well, CT or MRI perfusion scan showing favorable mismatch profile (Target mismatch profile on CT perfusion or MRI (ischemic core volume is <70ml, mismatch ratio is >1.8 and mismatch volume is >15ml)
  • 4. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or 2c with persistent occlusion(s) in terminal branches not amenable to MT.
  • 5. Signed informed consent

Exclusion criteria

  • 1. Premorbid modified Rankin scale (mRS) score of 4 or greater
  • 2. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT
  • 3. Platelet count <100,000
  • 4. Known bleeding diathesis
  • 5. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
  • 6. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR >1.8
  • 7. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
  • 8. Pregnant or lactating
  • 9. Previous known allergy to TNK
  • 10. Major surgery in past 30 days
  • 11. Patient is on or requires dialysis
  • 12. History of intracranial hemorrhage or serious head trauma at any time
  • 13. Any condition in the opinion of the enrolling physician that would preclude the patient from participating
  • 14. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
  • 15. Severe, uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) that is refractory to treatment
  • 16. History of acute ischemic stroke in the last 60 days
  • 17. Presumed septic embolus; suspicion of bacterial endocarditis
  • 18. Suspicion of aortic dissection
  • 19. Intracranial neoplasm
  • 20. Any mass effect
  • 21. Any terminal medical condition with life expectancy less than 6 months
  • 22. Concurrent enrollment in another trial that could confound the results of this study

Treatment and study plan

intra-arterial tenecteplase

Drug

intra-arterial drug administered after mechanical thrombectomy

Primary outcomes

  1. Incidence of Any Intracranial Hemorrhage and Neurologic Worsening

    Time frame: 24 hours (+/- 8 hours) post-treatment with intra-arterial Tenecteplase

    Number of participants with any incidence of 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 (+/- 8 hours) of treatment with IA TNK. This measure was assessed by imaging (NCCT/MRI) done within this time frame for all the enrolled study participants. This is the primary study-specific baseline measure for the ALLY study.

Secondary outcomes

  1. Ordinal Modified Rankin Scale Score

    Time frame: 90 days (+/- 30 days) post-treatment

    Ordinal modified Rankin Scale Score at 90 days (+/- 30 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). This assessment was assessed by the study site personnel. The mRS score could have been obtained over the phone via a structured questionnaire if all attempts to perform as in-person assessment had failed.

  2. Final Revascularization Grade

    Time frame: immediate post-treatment

    Final revascularization grade at end of IA treatment using the modified Thrombolysis in Cerebral Infarction (mTICI) scale.

    mTICI of grade 3: complete anterograde perfusion with normal filling of all distal branches.

    mTICI 2c is: Near complete anterograde perfusion to the tissue distal to the baseline occlusion but < 100% (slow flow in a few distal cortical vessels or presence of small distal cortical emboli).

    mTICI 2b is: Anterograde Perfusion to the tissue distal to the baseline occlusion but ≥ 50% of the target ischemic territory.

    The first bolus of intra-arterial TNK was given as soon as possible after mechanical thrombectomy. A dose of 1.5 mL (1 mg/mL) was infused over 1 minute.

    After 5 minutes, reperfusion was assessed. If TICI 3 was not achieved, a second 1.5 mg bolus was given, followed by another 5-minute assessment. If needed, a third 1.5 mg bolus was given in the same way. After the final 5-minute wait, the final mTICI score was recorded.

  3. Incidence of Any Asymptomatic Intracranial Hemorrhage

    Time frame: 24-Hour (+/- 8 hours) post-treatment

    Number of participants with any incidence of asymptomatic intracranial hemorrhage. This was assessed by the imaging done at 24 hours from the time of treatment. Both NCCT or MRI were acceptable but MRI was preferred.

  4. Number of Boluses

    Time frame: Immediate post-procedure

    Number of boluses given to achieve improvement in reperfusion to mTICI 2c and mTICI 3. This was assessed post-procedure immediately. The first bolus of intra-arterial (IA) tenecteplase (TNK) was given as soon as possible after the mechanical thrombectomy (MT) procedure was complete. A dose of 1.5 mL IA TNK (1 mg/mL) will be infused over 1 minute. After the infusion was complete, the investigator waited 5 minutes before checking the reperfusion status. If complete reperfusion (TICI 3) was not achieved, a second 1.5 mg bolus was given over 1 minute, followed again by a 5-minute waiting period before reassessment. If TICI 3 reperfusion was still not achieved, a third 1.5 mg bolus was administered over 1 minute. After this infusion, the investigator waited another 5 minutes and then assessed the reperfusion status. The final modified TICI (mTICI) score will be recorded after the last assessment.

  5. Mortality Rate at Discharge

    Time frame: Hospital Discharge (+/-1 day)

    This secondary outcome was determined when the participant was discharged, or it was determined on day 6(+/- 1 day).

Sponsors and collaborators

Lead sponsor

ProMedica Health System

Other

Collaborators

  • Genentech, Inc.

Registry information

Acronym: ALLY

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2021
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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