Clinical trial NCT05657470: Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK)
Official title: Rescue Thrombolysis for Medium Vessel Occlusion (RESCUE-TNK): a Prospective, Randomized, Open-label, Blinded End Point, and Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stroke, Ischemic
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
Collaborators: name: Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning
First posted: 2022-12-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: proportion of patients with successful Medium vessel occlusion (MeVO) recanalization
timeFrame: immediately after finishing intra-arterial tenecteplase
Secondary outcomes:
measure: proportion of modified Rankin Scale (mRS) 0-1
timeFrame: Day 90
measure: proportion of modified Rankin Scale (mRS) 0-2
timeFrame: Day 90
measure: distribution of modified Rankin Scale (mRS)
timeFrame: Day 90
measure: incidence of early neurological improvement
timeFrame: 24 (-6/+24) hours
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 24 (-6/+24) hours
measure: rate of visual recovery in patients with posterior cerebral artery occlusion
timeFrame: 7 days or at hospital discharge
measure: proportion of symptomatic intracranial hemorrhage
timeFrame: 24 (-6/+24) hours
measure: proportion of parenchymal hematoma type 1 and 2
timeFrame: 24 (-6/+24) hours
measure: all serious adverse events
timeFrame: 24 (-6/+24) hours
measure: all-cause death
timeFrame: 7 days
measure: recurrent stroke, cardiovascular events, other vascular events and death
timeFrame: 90 days
Other outcomes:
Locations:
city: ShenYang
country: China
facility: General Hospital of Northern Theater Command
Study officials:
References: