Intra-Arterial Tenecteplase After Clot Removal for Acute Ischemic Stroke

Trial details

Who runs it

Wake Forest University Health Sciences

Trial code

NCT06781385

Record updated

25 September 2026

Original description

The purpose of this study is to determine the safety and feasibility of using intra-arterial Tenecteplase in patients undergoing blood clot extraction for treatment of acute ischemic (non-bleeding) stroke. Intravenous Tenecteplase is FDA-approved to treat patients with an ischemic stroke presenting within the 0-3-hour time window.Read full original descriptionShow less

Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke

The purpose of this study is to determine the safety and feasibility of using intra-arterial Tenecteplase in patients undergoing blood clot extraction for treatment of acute ischemic (non-bleeding) stroke. Intravenous Tenecteplase is FDA-approved to treat patients with an ischemic stroke presenting within the 0-3-hour time window.

Inclusion: Patient/legally authorized representative has signed the Informed Consent Form; Ability to comply with the study protocol, in the investigator's judgment; Functionally independent (modified Rankin scale 0-2) prior to presentation; Baseline National Institutes of Health Stroke Scale (NIHSS) ≥ 6; Clinical syndrome consistent with occlusion of the internal carotid artery (ICA) or proximal middle cerebral artery (MCA), presenting within 4.5- to 24-hours of TLKW; Evidence of ICA, MCA-M1, or MCA-M2 occlusion on baseline computed tomography angiogram (CTA) or magnetic resonance angiogram (MRA). ICA/MCA tandem occlusions may be enrolled; Alberta Stroke Program Early Computed Tomography Score ≥ 6 on pre-thrombectomy unenhanced CT as determined by treating neurologist or reading radiologist; Pre-thrombectomy CTP or MRP with core infarction (cerebral blood flow < 30%) < 70 ml, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 ml (completed within 120 minutes of skin puncture for thrombectomy). If skin puncture occurs more than 120 minutes after the pre-thrombectomy CTP, enrollment may proceed at the PI's discretion; Endovascular thrombectomy of ICA, MCA-M1 or MCA-M2 occlusion performed according to local standard of care, defined as at least completing the initial diagnostic angiogram; CTP performed with RAPID AI AngioFlowTM within 30 minutes of thrombectomy completion; Modified thrombolysis in cerebral infarction (mTICI) 2b-3 revascularization following endovascular thrombectomy (EVT) (or after initial diagnostic angiogram); Presence of Tm > 6 lesion on post-EVT CTP of adequate quality for interpretation in the distribution of the symptomatic occlusion.

Exclusion: Current participation in another investigational drug or device study; Systolic blood pressure > 185 mm Hg or diastolic blood pressure > 110 mm Hg after EVT, refractory to medical therapy; Treatment with a thrombolytic within the last 3 months prior to randomization; Intracranial or intraspinal surgery or trauma within 2 months; Placement of cervical carotid or intracranial stent during thrombectomy procedure requiring dual antiplatelet therapy; Known hypersensitivity or allergy to any ingredients of tenecteplase; Active internal bleeding; Known bleeding diathesis (e.g., Alzheimer's patients taking lecanemab); Intracranial malignant neoplasm, arteriovenous malformation, or unsecured aneurysm > 1 cm; Other serious, advanced, or terminal illness (investigator's judgment) or life expectancy is less than 6 months; History of acute ischemic stroke in the last 90 days; History of hemorrhagic stroke; Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was to be performed; Acute intracranial hemorrhage on pre-thrombectomy imaging or suspected acute intracranial hemorrhage after EVT; Significant hemispheric mass effect or any amount of midline shift due to acute stroke; Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 1.7; Baseline platelet count < 100,000/mcL (results must be available prior to treatment); Baseline blood glucose > 400 mg/dL (22.20 mmol/L); Baseline blood glucose < 50 mg/dL; needs to be normalized prior to randomization; Use of one of the new oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban); Presumed septic embolus; suspicion of bacterial endocarditis; Pregnant; Acute bilateral strokes on initial imaging; Multiple acute intracranial occlusions (except ICA/MCA) on initial CTA or MRA.

ClinicalTrials.gov NCT06781385