Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05657470
• Other study ID #: Y (2022) 187
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 21, 2023
• Est. completion date: March 15, 2025

Study information

• Verified date: March 2023
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke, Ischemic

Intervention

Drug:
• Tenecteplase
intra-arterial tenecteplase

Locations

Country	Name	City	State
China	General Hospital of Northern Theater Command	ShenYang

Sponsors (2)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region	Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	proportion of modified Rankin Scale (mRS) 0-1	mRS scores range from 0 to 6, with higher scores indicating worse outcome	Day 90
Secondary	proportion of modified Rankin Scale (mRS) 0-2	mRS scores range from 0 to 6, with higher scores indicating worse outcome	Day 90
Secondary	distribution of modified Rankin Scale (mRS)	mRS scores range from 0 to 6, with higher scores indicating worse outcome	Day 90
Secondary	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
Secondary	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
Secondary	rate of visual recovery in patients with posterior cerebral artery occlusion		7 days or at hospital discharge
Secondary	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
Secondary	proportion of parenchymal hematoma type 1 and 2		24 (-6/+24) hours
Secondary	all serious adverse events		24 (-6/+24) hours
Secondary	all-cause death		7 days
Secondary	recurrent stroke, cardiovascular events, other vascular events and death		90 days