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Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

Primary Purpose

Stroke, Ischemic

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tenecteplase
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

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

Inclusion Criteria: Age ≥18 years; Medium vessel occlusion (MeVO), referring to M2-3 of MCA; A1-3 of ACA; P1-3 of PCA; PICA, AICA or SCA (including primary, distal embolism in the same region after thrombectomy or concurrent embolism in other regions). Primary MeVO as detected by the first DSA examination or secondary MeVO after mechanical thrombectomy for large vessel occlusion; MeVO causes neurological deficits in motor strength, language, vision etc; Endovascular mechanical thrombectomy cannot be performed as assessed by the investigator; Absence of parenchymal hematoma on CT images performed in the angio suite. Within 24 hours from symptom onset; Signed informed consent by patient or patient's legally authorized representative. Exclusion Criteria: Patients with completed infarction in the territory of the MeVO on non-contrast CT; Patients with intracranial hemorrhage; Coagulation disorders, tendency for systemic hemorrhagic, thrombocytopenia (<100,000/mm3); Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; After mechanical thrombectomy, severe and sustained (> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg); Patients with contraindication or allergy to any ingredient of study medication; Pregnancy, plan to get pregnant or active lactation; The estimated life expectancy is less than 6 months due to other serious diseases; Other conditions unsuitable for this clinical study as assessed by researcher.

Sites / Locations

  • General Hospital of Northern Theater CommandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TNK group

control group

Arm Description

Outcomes

Primary Outcome Measures

proportion of patients with successful Medium vessel occlusion (MeVO) recanalization
successful MeVO recanalization is defined as the expanded treatment in cerebral ischemia (eTICI) score 2b67-3 in the territory of the target occluded MeVO artery

Secondary Outcome Measures

proportion of modified Rankin Scale (mRS) 0-1
mRS scores range from 0 to 6, with higher scores indicating worse outcome
proportion of modified Rankin Scale (mRS) 0-2
mRS scores range from 0 to 6, with higher scores indicating worse outcome
distribution of modified Rankin Scale (mRS)
mRS scores range from 0 to 6, with higher scores indicating worse outcome
incidence of early neurological improvement
early neurological improvement is defined as a decrease of more than 4 points or reaching 0 points in NIHSS score, compared with baseline
Changes in National Institute of Health stroke scale (NIHSS)
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
rate of visual recovery in patients with posterior cerebral artery occlusion
proportion of symptomatic intracranial hemorrhage
symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage
proportion of parenchymal hematoma type 1 and 2
all serious adverse events
all-cause death
recurrent stroke, cardiovascular events, other vascular events and death

Full Information

First Posted
December 2, 2022
Last Updated
March 21, 2023
Sponsor
General Hospital of Shenyang Military Region
Collaborators
Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
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1. Study Identification

Unique Protocol Identification Number
NCT05657470
Brief Title
Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)
Official Title
Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK): a Prospective, Randomized, Open-label, Blinded End Point, and Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2023 (Actual)
Primary Completion Date
March 15, 2025 (Anticipated)
Study Completion Date
March 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region
Collaborators
Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The best reperfusion strategy for medium-sized vessel occlusion (MeVO) is not well established. Given the proven treatment effect of intra-arterial thrombolysis in patients with large vessel occlusion (LVO), the investigators hypothesized that intra-arterial tenecteplase (TNK) could increase the recanalization rate of MeVO and thus improve clinical outcome. The current study aimed to explore the safety and efficacy of intra-arterial TNK in patients with MeVO.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TNK group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Tenecteplase
Intervention Description
intra-arterial tenecteplase
Primary Outcome Measure Information:
Title
proportion of patients with successful Medium vessel occlusion (MeVO) recanalization
Description
successful MeVO recanalization is defined as the expanded treatment in cerebral ischemia (eTICI) score 2b67-3 in the territory of the target occluded MeVO artery
Time Frame
immediately after finishing intra-arterial tenecteplase
Secondary Outcome Measure Information:
Title
proportion of modified Rankin Scale (mRS) 0-1
Description
mRS scores range from 0 to 6, with higher scores indicating worse outcome
Time Frame
Day 90
Title
proportion of modified Rankin Scale (mRS) 0-2
Description
mRS scores range from 0 to 6, with higher scores indicating worse outcome
Time Frame
Day 90
Title
distribution of modified Rankin Scale (mRS)
Description
mRS scores range from 0 to 6, with higher scores indicating worse outcome
Time Frame
Day 90
Title
incidence of early neurological improvement
Description
early neurological improvement is defined as a decrease of more than 4 points or reaching 0 points in NIHSS score, compared with baseline
Time Frame
24 (-6/+24) hours
Title
Changes in National Institute of Health stroke scale (NIHSS)
Description
NIHSS scores range 0-42, with higher scores indicating greater stroke severity
Time Frame
24 (-6/+24) hours
Title
rate of visual recovery in patients with posterior cerebral artery occlusion
Time Frame
7 days or at hospital discharge
Title
proportion of symptomatic intracranial hemorrhage
Description
symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage
Time Frame
24 (-6/+24) hours
Title
proportion of parenchymal hematoma type 1 and 2
Time Frame
24 (-6/+24) hours
Title
all serious adverse events
Time Frame
24 (-6/+24) hours
Title
all-cause death
Time Frame
7 days
Title
recurrent stroke, cardiovascular events, other vascular events and death
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years; Medium vessel occlusion (MeVO), referring to M2-3 of MCA; A1-3 of ACA; P1-3 of PCA; PICA, AICA or SCA (including primary, distal embolism in the same region after thrombectomy or concurrent embolism in other regions). Primary MeVO as detected by the first DSA examination or secondary MeVO after mechanical thrombectomy for large vessel occlusion; MeVO causes neurological deficits in motor strength, language, vision etc; Endovascular mechanical thrombectomy cannot be performed as assessed by the investigator; Absence of parenchymal hematoma on CT images performed in the angio suite. Within 24 hours from symptom onset; Signed informed consent by patient or patient's legally authorized representative. Exclusion Criteria: Patients with completed infarction in the territory of the MeVO on non-contrast CT; Patients with intracranial hemorrhage; Coagulation disorders, tendency for systemic hemorrhagic, thrombocytopenia (<100,000/mm3); Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; After mechanical thrombectomy, severe and sustained (> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg); Patients with contraindication or allergy to any ingredient of study medication; Pregnancy, plan to get pregnant or active lactation; The estimated life expectancy is less than 6 months due to other serious diseases; Other conditions unsuitable for this clinical study as assessed by researcher.
Facility Information:
Facility Name
General Hospital of Northern Theater Command
City
ShenYang
ZIP/Postal Code
110840
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zi-Ai Zhao
Phone
+862428897491
Email
zhaoziai@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

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