Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

Phase 2

Recruiting

• Conditions: Stroke, Ischemic
• Interventions: Drug: Tenecteplase

• Registration Number: NCT05657470
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-10
• Study First Posted: 2022-12-20
• Study Start: 2023-03-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-06
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-09-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNK group	Tenecteplase	-

Primary Outcome Measures

Name	Time	Method
proportion of patients with successful Medium vessel occlusion (MeVO) recanalization	immediately after finishing intra-arterial tenecteplase	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

Name	Time	Method
proportion of modified Rankin Scale (mRS) 0-2	Day 90	mRS scores range from 0 to 6, with higher scores indicating worse outcome
distribution of modified Rankin Scale (mRS)	Day 90	mRS scores range from 0 to 6, with higher scores indicating worse outcome
recurrent stroke, cardiovascular events, other vascular events and death	90 days
proportion of parenchymal hematoma type 1 and 2	24 (-6/+24) hours
incidence of early neurological improvement	24 (-6/+24) hours	early neurological improvement is defined as a decrease of more than 4 points or reaching 0 points in NIHSS score, compared with baseline
proportion of modified Rankin Scale (mRS) 0-1	Day 90	mRS scores range from 0 to 6, with higher scores indicating worse outcome
proportion of symptomatic intracranial hemorrhage	24 (-6/+24) hours	symptomatic intracranial hemorrhage is defined as an increase in the NIHSS score of ≥4 points as a result of the intracranial hemorrhage
Changes in National Institute of Health stroke scale (NIHSS)	24 (-6/+24) hours	NIHSS scores range 0-42, with higher scores indicating greater stroke severity
rate of visual recovery in patients with posterior cerebral artery occlusion	7 days or at hospital discharge
all serious adverse events	24 (-6/+24) hours
all-cause death	7 days

Trial Locations

Locations (1)

General Hospital of Northern Theater Command; 🇨🇳 ShenYang, China