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
- Are there results?
- Not yet: the study is under way
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
Show all 12Show fewer
- 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
Show all 24Show fewer
- 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.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Arterial Tenecteplase Following Endovascular Thrombectomy for Large Vessel Occlusion Stroke
- ClinicalTrials.gov ID
- NCT06781385
- Acronym / sponsor ID
- TNK-FLOW / IRB00121066
- Conditions
- Acute Ischemic Stroke
- Keywords
- brain hemorrhage, stroke, blood clot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial Tenecteplase | Experimental | Drug: Intra-arterial TenecteplaseFollowing 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. |
| Intra-arterial Saline | Placebo comparator | Drug: Intra-arterial SalineFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-arterial TenecteplaseOne-time dose of intra-arterial tenecteplase post-thrombectomy | Drug | Intra-arterial Tenecteplase |
| Intra-arterial SalineOne-time dose of intra-arterial saline post-thrombectomy | Drug | Intra-arterial Saline |
Primary outcome
Participants with Change in Symptomatic Intracranial Hemorrhage
Time frame: Hour 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 1
Time frame: 24 Hours
Number of participants with parenchymal hematoma type 1
Participants with Parenchymal Hematoma Type 2
Time frame: 24 Hours
Number of participants with parenchymal hematoma type 2
30-Day Mortality Count
Time frame: Day 30
Number of patients expired
90-Day Mortality Count
Time frame: Day 90
Number of patients expired
Number of Grade 3 Adverse Events
Time frame: Hour 24
Total number of grade 3 adverse events
Number of Grade 3 Adverse Events
Time frame: Day 5
Total number of grade 3 adverse events
Number of Grade 3 Adverse Events
Time frame: Day 30
Total number of grade 3 adverse events
Number of Grade 3 Adverse Events
Time frame: Day 90
Total number of grade 3 adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahul Karamchandani, MD principal investigator
Atrium Health Neurosciences Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants with Change in Symptomatic Intracranial Hemorrhage (time frame: Hour 36). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.