Acute Ischemic StrokePhase 2TNK-FLOWNCT06781385
Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke
A Phase 2 study testing Intra-arterial Tenecteplase and Intra-arterial Saline in people with Acute Ischemic Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intra-arterial Tenecteplase and Intra-arterial Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2025to Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health Neurosciences Institute
Charlotte, North Carolina, 28207
About this study
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 the detailed description
The primary objective of this study is to determine the safety and feasibility of intra-arterial Tenecteplase in selected patients with persistent post-thrombectomy hypoperfusion on computed tomography perfusion based on symptomatic intracranial hemorrhage (parenchymal hematoma type 2, subarachnoid hemorrhage, and/or intraventricular hemorrhage producing decline from the initial NIHSS of ≥ 4 points) at 24-36 hours.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intra-arterial Tenecteplase, Intra-arterial Saline
- Keywords
- brain hemorrhage, stroke, blood clot
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages, Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arterial TenecteplaseDrug
One-time dose of intra-arterial tenecteplase post-thrombectomy
Intra-arterial SalineDrug
One-time dose of intra-arterial saline post-thrombectomy
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial Tenecteplase | Experimental | Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of intra-arterial Tenecteplase (0.125 mg/kg, maximum dose 12.5 mg) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist. Receives: Drug: Intra-arterial Tenecteplase |
| Intra-arterial Saline | Placebo comparator | Following endovascular thrombectomy for large vessel occlusion stroke one-time dose of saline (0.9% NaCl solution) will be delivered over 5-10 seconds by the treating neuro-interventionalist through a microcatheter positioned as close as possible to the residual thrombus or as distal as possible in the originating vessel, per the discretion of the neuro-interventionalist. Receives: Drug: Intra-arterial Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants with Change in Symptomatic Intracranial Hemorrhage
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.
Measured: Hour 36
Participants with Parenchymal Hematoma Type 1
Number of participants with parenchymal hematoma type 1
Measured: 24 Hours
Participants with Parenchymal Hematoma Type 2
Number of participants with parenchymal hematoma type 2
Measured: 24 Hours
30-Day Mortality Count
Number of patients expired
Measured: Day 30
90-Day Mortality Count
Number of patients expired
Measured: Day 90
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Measured: Hour 24
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Measured: Day 5
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Measured: Day 30
Number of Grade 3 Adverse Events
Total number of grade 3 adverse events
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start22 Sep 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Rahul Karamchandani, MD, Principal investigator, Atrium Health Neurosciences Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06781385
- Sponsor's protocol ID
- IRB00121066
- Other IDs
- 40010317
- Acronym
- TNK-FLOW
- Status last verified
- Sep 2026
- First submitted
- 13 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No