Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status and phase

Terminated

Phase 3

Conditions

Stroke, Ischemic

Treatments

Drug: Tenecteplase

Study type

Interventional

Funder types

Other

Identifiers

NCT05657457

Y (2022) 185

Details and patient eligibility

About

The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. The current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.

Enrollment

145 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18
Patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per BASICS trial definition;
National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
Successful recanalization (mTICI 2b-3) after endovascular treatment;
PC-ASPECTS ≥ 6 on CT;
Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
Modified Rankin Scale score before stroke onset ≤ 3;
Signed informed consent by patient or their legally authorized representative.

Exclusion criteria

baseline PC ASPECTS < 5 on CT;
More than six retrieval attempts in the same vessel;
Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
Coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (<100000/mm3), or INR > 1.7;
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;
After recanalization, severe and sustained (i.e., > 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
Patients with contraindication or allergic to any ingredient of drugs in our study
Pregnancy, plan to get pregnant or during lactation
The estimated life expectancy is less than 6 months due to other serious diseases;
Other conditions unsuitable for this clinical study assessed by researcher.