Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

Ischemic Stroke Clinical Trial

— ALLY  

Official title:

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05172934
• Other study ID #: ALLY
• Status: Completed
• Phase: Phase 2
• Start date: March 15, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: December 2023
• Source: ProMedica Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke

Intervention

Drug:
• intra-arterial tenecteplase
intra-arterial drug administered after mechanical thrombectomy

Locations

Country	Name	City	State
United States	ProMedica Toledo Hospital	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
ProMedica Health System	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improved reperfusion	Proportion of patients with improved reperfusion (mTICI 2c/3) at end of IA treatment	immediate post-treatment
Secondary	Improved reperfusion	Proportion of patients with improvement of reperfusion to mTICI 2c, mTICI 3, and mTICI 2c-3.	immediate post-treatment
Secondary	Ordinal modified Rankin Scale Score	Ordinal modified Rankin Scale Score at 90 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).	90 days post-treatment
Secondary	Functional Independence	Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days	90 days post-treatment
Secondary	Final revascularization grade	Final revascularization grade at end of IA treatment using the modified Thrombolysis in Cerebral Infarction (mTICI) grading scale.	immediate post-treatment
Secondary	Mortality	Mortality rate at discharge	Hospital Discharge (Day 6 post-randomization (+/- 1 day))
Secondary	Asymptomatic intracranial hemorrhage	Incidence of any asymptomatic intracranial hemorrhage	24 hours post-treatment
Secondary	Mean number of boluses	Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3	Immediate post-procedure