NCT06781385
Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke
Enrolling by Invitation
PHASE2Ages 18+InterventionalTreatmentWake Forest University Health SciencesInvestigator-initiated
~40 participants
Updated 2026-06-02 on ClinicalTrials.gov
What's tested:Intra-arterial TenecteplaseIntra-arterial Saline
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participants with Change in Symptomatic Intracranial Hemorrhage
Measured over Hour 36
+8 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Study leadership
- Rahul Karamchandani, MD · PRINCIPAL_INVESTIGATOR · Atrium Health Neurosciences Institute
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
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
Known hypersensitivity or allergy to any ingredients of tenecteplase
Active internal bleeding
Known bleeding diathesis (e.g., Alzheimer's patients taking lecanemab)
Systolic blood pressure \> 185 mm Hg or diastolic blood pressure \> 110 mm Hg after EVT, refractory to medical therapy
Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR \> 1.7
Use of one of the new oral anticoagulants within the last 48 hours (dabigatran, rivaroxaban, apixaban, edoxaban)
Treatment with a thrombolytic within the last 3 months prior to randomization
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
Intracranial or intraspinal surgery or trauma within 2 months
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
Presumed septic embolus; suspicion of bacterial endocarditis
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
Pregnant
Acute intracranial hemorrhage on pre-thrombectomy imaging or suspected acute intracranial hemorrhage after EVT
Acute bilateral strokes on initial imaging
Multiple acute intracranial occlusions (except ICA/MCA) on initial CTA or MRA
Significant hemispheric mass effect or any amount of midline shift due to acute stroke
Placement of cervical carotid or intracranial stent during thrombectomy procedure requiring dual antiplatelet therapy
What this trial measures
- Participants with Change in Symptomatic Intracranial HemorrhageHour 36
Number of participants with symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage) producing decline from the initial National Institutes of Health Stroke Scale (NIHSS) of ≥ 4 points.
- Participants with Parenchymal Hematoma Type 124 Hours
Number of participants with parenchymal hematoma type 1
- Participants with Parenchymal Hematoma Type 224 Hours
Number of participants with parenchymal hematoma type 2
- 30-Day Mortality CountDay 30
Number of patients expired
- 90-Day Mortality CountDay 90
Number of patients expired
- Number of Grade 3 Adverse EventsHour 24
Total number of grade 3 adverse events
- Number of Grade 3 Adverse EventsDay 5
Total number of grade 3 adverse events
- Number of Grade 3 Adverse EventsDay 30
Total number of grade 3 adverse events
- Number of Grade 3 Adverse EventsDay 90
Total number of grade 3 adverse events