Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK): a Prospective, Randomized, Open-label, Blinded End Point, and Multicenter Trial

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Drug: Tenecteplase

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • ShenYang, China, 110840
    • General Hospital of Northern Theater Command

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥18 years;

2. 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.
3. Within 24 hours from symptom onset;
4. Signed informed consent by patient or patient's legally authorized representative.

Exclusion Criteria:

1. Patients with completed infarction in the territory of the MeVO on non-contrast CT;
2. Patients with intracranial hemorrhage;
3. Coagulation disorders, tendency for systemic hemorrhagic, thrombocytopenia (<100,000/mm3);
4. 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;
5. After mechanical thrombectomy, severe and sustained (> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg);
6. Patients with contraindication or allergy to any ingredient of study medication;
7. Pregnancy, plan to get pregnant or active lactation;
8. The estimated life expectancy is less than 6 months due to other serious diseases;
9. Other conditions unsuitable for this clinical study as assessed by researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: TNK group	Drug: Tenecteplase; intra-arterial tenecteplase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	immediately after finishing intra-arterial tenecteplase

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of modified Rankin Scale (mRS) 0-1	mRS scores range from 0 to 6, with higher scores indicating worse outcome	Day 90
proportion of modified Rankin Scale (mRS) 0-2	mRS scores range from 0 to 6, with higher scores indicating worse outcome	Day 90
distribution of modified Rankin Scale (mRS)	mRS scores range from 0 to 6, with higher scores indicating worse outcome	Day 90
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	24 (-6/+24) hours
Changes in National Institute of Health stroke scale (NIHSS)	NIHSS scores range 0-42, with higher scores indicating greater stroke severity	24 (-6/+24) hours
rate of visual recovery in patients with posterior cerebral artery occlusion		7 days or at hospital discharge
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	24 (-6/+24) hours
proportion of parenchymal hematoma type 1 and 2		24 (-6/+24) hours
all serious adverse events		24 (-6/+24) hours
all-cause death		7 days
recurrent stroke, cardiovascular events, other vascular events and death		90 days

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Collaborators: Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 10, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Fibrinolytic Agents; Tenecteplase
• Other Study ID Numbers: Y (2022) 187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No