Back to results

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

Primary Purpose

Ischemic Stroke

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

intra-arterial tenecteplase

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring thrombolytic, stroke, distal emboli

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ProMedica Toledo HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intra-arterial Tenecteplase

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improved reperfusion

Proportion of patients with improved reperfusion (mTICI 2c/3) at end of IA treatment

Improved reperfusion

Proportion of patients with improvement of reperfusion to mTICI 2c, mTICI 3, and mTICI 2c-3.

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).

Functional Independence

Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days

Final revascularization grade

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

Mortality

Mortality rate at discharge

Asymptomatic intracranial hemorrhage

Incidence of any asymptomatic intracranial hemorrhage

Mean number of boluses

Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3

Full Information

NCT ID

NCT05172934

First Posted

November 16, 2021

Last Updated

April 19, 2023

Sponsor

ProMedica Health System

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05172934

Brief Title

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

Acronym

ALLY

Official Title

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 15, 2022 (Actual)

Primary Completion Date

December 15, 2024 (Anticipated)

Study Completion Date

December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ProMedica Health System

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

thrombolytic, stroke, distal emboli

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intra-arterial Tenecteplase

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

intra-arterial tenecteplase

Intervention Description

intra-arterial drug administered after mechanical thrombectomy

Primary Outcome Measure Information:

Title

Incidence of any intracranial hemorrhage and neurologic worsening

Description

Time Frame

24 hours post-treatment with intra-arterial Tenecteplase

Secondary Outcome Measure Information:

Title

Improved reperfusion

Description

Proportion of patients with improved reperfusion (mTICI 2c/3) at end of IA treatment

Time Frame

immediate post-treatment

Title

Improved reperfusion

Description

Proportion of patients with improvement of reperfusion to mTICI 2c, mTICI 3, and mTICI 2c-3.

Time Frame

immediate post-treatment

Title

Ordinal modified Rankin Scale Score

Description

Time Frame

90 days post-treatment

Title

Functional Independence

Description

Proportion of patients with functional independence, defined as a mRS of 0-2 at 90 days

Time Frame

90 days post-treatment

Title

Final revascularization grade

Description

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

Time Frame

immediate post-treatment

Title

Mortality

Description

Mortality rate at discharge

Time Frame

Hospital Discharge (Day 6 post-randomization (+/- 1 day))

Title

Asymptomatic intracranial hemorrhage

Description

Incidence of any asymptomatic intracranial hemorrhage

Time Frame

24 hours post-treatment

Title

Mean number of boluses

Description

Mean number of boluses to achieve improvement in reperfusion to mTICI 2c and mTICI 3

Time Frame

Immediate post-procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Syed F Zaidi, MD

Phone

419-291-3306

syed.zaidiMD@promedica.org

First Name & Middle Initial & Last Name or Official Title & Degree

Alicia C Castonguay, PhD

Phone

419-291-1895

alicia.castonguay@utoledo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Syed F Zaidi, MD

Organizational Affiliation

ProMedica Health System

Official's Role

Principal Investigator

Facility Information:

Facility Name

ProMedica Toledo Hospital

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43606

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Syed Zaidat, MD

Phone

419-291-2014

First Name & Middle Initial & Last Name & Degree

Syed Zaidat, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Adjunctive Intra-arterial Tenecteplase Following Mechanical Thrombectomy Pilot Trial

We'll reach out to this number within 24 hrs