Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

NCT ID: NCT05657470

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2025-06-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TNK group

Group Type: EXPERIMENTAL

Tenecteplase

Intervention Type: DRUG

intra-arterial tenecteplase

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tenecteplase

intra-arterial tenecteplase

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

UNKNOWN

Sponsor Role: collaborator

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Head of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

Other Identifiers

Y (2022) 187

Identifier Type: -

Identifier Source: org_study_id