Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

NCT05657470 | Completed Phase 2 DMC

• 1 other identifier: Y (2022) 187
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• proportion of modified Rankin Scale (mRS) 0-1

  Day 90

• proportion of modified Rankin Scale (mRS) 0-2

  Day 90

• distribution of modified Rankin Scale (mRS)

  Day 90

• incidence of early neurological improvement

  24 (-6/+24) hours

• Changes in National Institute of Health stroke scale (NIHSS)

  24 (-6/+24) hours

Study Arms (2)

TNK group

EXPERIMENTAL

Drug: Tenecteplase

control group

NO INTERVENTION

Interventions

Tenecteplase DRUG

intra-arterial tenecteplase

TNK group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead
• Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning: collaborator

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 20, 2022
• Study Start: March 21, 2023
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

CN (1)