Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

NCT ID: NCT05172934

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2023-11-01

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.

Detailed Description

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-arterial Tenecteplase

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

Group Type: EXPERIMENTAL

intra-arterial tenecteplase

Intervention Type: DRUG

intra-arterial drug administered after mechanical thrombectomy

Interventions

intra-arterial tenecteplase

intra-arterial drug administered after mechanical thrombectomy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

ProMedica Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Syed F Zaidi, MD

Role: PRINCIPAL_INVESTIGATOR

ProMedica Health System

Locations

ProMedica Toledo Hospital

Toledo, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39772606 (View on PubMed)

Other Identifiers

ALLY

Identifier Type: -

Identifier Source: org_study_id