Using tenecteplase to treat medium vessel occlusion in stroke patients

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

This study is testing if a new treatment called tenecteplase can help stroke patients with medium vessel blockages recover better when they can't have surgery to remove the blockage.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: General Hospital of Shenyang Military Region (other)
• Locations: 1 site (ShenYang)
• Trial ID: NCT05657470 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of intra-arterial tenecteplase (TNK) for patients suffering from medium vessel occlusion (MeVO) due to ischemic stroke. The study aims to determine whether TNK can improve recanalization rates and clinical outcomes in these patients, who are not candidates for mechanical thrombectomy. Participants must be adults with neurological deficits caused by MeVO and must enroll within 24 hours of symptom onset. The trial will assess the treatment's effectiveness compared to existing reperfusion strategies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with medium vessel occlusion causing neurological deficits who cannot undergo mechanical thrombectomy.

Not a fit: Patients with completed infarction in the territory of the medium vessel occlusion or those with intracranial hemorrhage will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for stroke patients with medium vessel occlusion.

How similar studies have performed: While intra-arterial thrombolysis has shown success in large vessel occlusions, this approach for medium vessel occlusions is relatively novel and has not been extensively tested.

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.

Where this trial is running

ShenYang

• General Hospital of Northern Theater Command — ShenYang, China (RECRUITING)

Conditions: Stroke, Ischemic