Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

NCT05172934 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ALLY
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke

Keywords

thrombolytic; stroke; distal emboli

Outcome Measures

Primary Outcomes (1)

• Incidence of any intracranial hemorrhage and neurologic worsening

  Incidence of any 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 of treatment with IA TNK

  24 hours post-treatment with intra-arterial Tenecteplase

Secondary Outcomes (8)

• Improved reperfusion

  immediate post-treatment

• Improved reperfusion

  immediate post-treatment

• Ordinal modified Rankin Scale Score

  90 days post-treatment

• Functional Independence

  90 days post-treatment

• Final revascularization grade

  immediate post-treatment

Study Arms (1)

Intra-arterial Tenecteplase

EXPERIMENTAL

Participants will receive intra-arterial Tenecteplase after achieving mTICI 2b or 2c reperfusion with standard of care MT.

Drug: intra-arterial tenecteplase

Interventions

intra-arterial tenecteplase DRUG

intra-arterial drug administered after mechanical thrombectomy

Intra-arterial Tenecteplase

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• \. 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)
• \. Post-mechanical thrombectomy with ≤5 device passes and mTICI grade 2b or 2c with persistent occlusion(s) in terminal branches not amenable to MT.
• \. Signed informed consent

You may not qualify if:

• \. Premorbid modified Rankin scale (mRS) score of 4 or greater
• \. Presence of any hemorrhage and/or ASPECT score ≤6 on baseline head CT
• \. Platelet count \<100,000
• \. Known bleeding diathesis
• \. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
• \. Active anticoagulation treatment with novel oral anticoagulant (NOACs) taken within the last 48 hours, or INR \>1.8
• \. Patients requiring active treatment with dual antiplatelet agents (e.g. proximal cervical carotid artery stenting)
• \. Pregnant or lactating
• \. Previous known allergy to TNK
• \. Major surgery in past 30 days
• \. Patient is on or requires dialysis
• \. History of intracranial hemorrhage or serious head trauma at any time
• \. Any condition in the opinion of the enrolling physician that would preclude the patient from participating
• \. Pre-existing medical, neurological, or psychiatric disease that would confound the neurological or functional evaluation
• \. Severe, uncontrolled hypertension (systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg) that is refractory to treatment

Sponsors & Collaborators

• ProMedica Health System: lead
• Genentech, Inc.: collaborator

Study Sites (1)

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Related Publications (1)

• Zaidi SF, Castonguay AC, Zaidat OO, Jadhav AP, Sheth SA, Haussen DC, Nguyen TN, Burgess RE, Alhajala HS, Gharaibeh K, Salahuddin H, Rao R, Oliver MJ, Jumaa MA. Safety of Adjunctive Intraarterial Tenecteplase Following Mechanical Thrombectomy: The ALLY Pilot Trial. Stroke. 2025 Feb;56(2):355-361. doi: 10.1161/STROKEAHA.124.048846. Epub 2025 Jan 8.

  PMID: 39772606 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Syed F Zaidi, MD

  ProMedica Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive intra-arterial Tenecteplase after achieving mTICI 2b or 2c reperfusion with standard of care mechanical thrombectomy.

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 29, 2021
• Study Start: March 15, 2022
• Primary Completion: September 12, 2023
• Study Completion: November 1, 2023
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)