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

NCT ID: NCT05657457

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-21
• Study Completion Date: 2025-05-18

Brief Summary

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.

Conditions

Stroke, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

TNK group

Group Type: EXPERIMENTAL

Tenecteplase

Intervention Type: DRUG

intra-arterial tenecteplase

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tenecteplase

intra-arterial tenecteplase

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerebrovascular Disease Collaboration & Innovation Alliance of Liaoning

UNKNOWN

Sponsor Role: collaborator

General Hospital of Shenyang Military Region

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Head of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Hospital of Northern Theater Command

Shenyang, , China

Countries

China

Other Identifiers

Y (2022) 185

Identifier Type: -

Identifier Source: org_study_id