Acute Ischemic Stroke From Large Vessel OcclusionPhase 2INTIMA-MTNCT06904911
Intra-Arterial Tenecteplase to Improve the Microvascular Hemodynamics After Mechanical Thrombectomy
A Phase 2 study testing intra-arterial tenecteplase administration in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a prospective, single-arm, open-label study to evaluate the efficacy of intra-arterial tenecteplase in improving microvascular reperfusion following successful large vessel recanalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke From Large Vessel Occlusion
- What is being tested?
- intra-arterial tenecteplase administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to 30 Dec 2026
- 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
- At least 18 years of age
- Ability to comply with the study protocol, in the investigator's judgment
- Acute ischemic stroke attributed to anterior circulation large vessel occlusion (of the internal carotid artery or first segment of the middle cerebral artery based on CTA, MRA, or catheter angiogram) being treated with mechanical thrombectomy
- NIHSS ≥ 6 at the initiation of endovascular therapy (arterial puncture)
- Time from stroke onset to IA-TNK administration < 24 hours. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline
Show all 9Show fewer
- ASPECTS ≥ 6 on pre-MT CT imaging
- If treated > 6 hours from stroke onset, CTP imaging must demonstrates favorable mismatch profile (based on RAPID processing: infarct core <70 mL, mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 mL)
- Qualifying neuroimaging (CT and CTP, if applicable) must be obtained <120 minutes prior to arterial puncture.
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 (Alzheimer's patients taking lecanemab)
- 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)
Show all 32Show fewer
- Treatment with a thrombolytic within the last 3 months prior to randomization, inclusive of intravenous thrombolysis during the index stroke.
- Baseline platelet count < 100,000/microliter (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
- 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
- Systolic BP >185 mmHg or diastolic BP >110 mmHg, refractory to treatment
- Suspicion of aortic dissection
- Known allergy to iodine or iodinated contrast
- Subject who requires hemodialysis or peritoneal dialysis, or who have a contraindication to an angiogram
- Renal failure as defined by a serum creatinine > 3.0 mg/dl or GFR < 30
- Known intracranial neoplasm
- GI bleeding within the past 21 days
- Pre-existing medical or neurological disease that will confound the neurological or functional evaluations
- Premorbid (prior to the index stroke) modified Rankin Scale (mRS) score ≥ 3
- Additional neuroimaging exclusion criteria:
- ASPECTS <6 on pre-MT CT imaging
- Acute intracranial hemorrhage or contrast extravasation on CT before or immediately after MT (prior to study drug administration)
- Significant mass effect with midline shift on non-contrast CT before or immediately after MT
- Cervical or intracranial stent placement during endovascular therapy
- Acute symptomatic arterial occlusions in more than one vascular territory confirmed on CTA, MRA, or catheter angiography
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, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Nichole Gallatti, 215-349-8651, nichole.gallatti@pennmedicine.upenn.edu
Christopher Favilla, M.D
About this study
This is a prospective, single-arm, open-label study to evaluate the efficacy of intra-arterial tenecteplase in improving microvascular reperfusion following successful large vessel recanalization. Acute ischemic stroke patients with large anterior circulation large vessel occlusion will receive a single weight-based dose of intra-arterial tenecteplase after achieving successful large vessel recanalization (defined as TICI ≥ 2b) via standard of care mechanical thrombectomy. Microvascular flow will be assessed by quantitative angiography before and after the intra-arterial drug administration in order to quantify the impact of targeted thrombolysis on microvascular reperfusion. Reperfusion will be secondarily assessed with 24-hour imaging, final infarct volume will be quantified 72 hours following treatment, and functional outcome will be assessed in the short-term by the NIHSS and in the long-term by the 90-day modified Rankin Scale.
Read the detailed description
This is a prospective, single-arm, open-label pilot trial to evaluate the efficacy of IA-TNK in improving microvascular reperfusion following successful large vessel recanalization. Acute ischemic stroke patients will receive IA-TNK after achieving mTICI ≥ 2b recanalization via standard of care mechanical thrombectomy (MT). Microvascular flow will be assessed by quantitative angiography before and after IA-TNK to quantify the impact of targeted thrombolysis on microvascular reperfusion. Reperfusion will be secondarily assessed with 24-hour imaging. Final infarct volume will be quantified 72 hours following treatment. Functional outcome will be assessed in the short-term by the NIHSS and at 90-days by the modified Rankin Scale.
N=20 acute stroke patients will be enrolled after successful recanalization of a proximal anterior circulation LVO (internal carotid artery or first segment of the middle cerebral artery). After standard of care MT, every patient will undergo a quantitative angiographic assessment with syngo iFLOW (Siemens Healthineers). More specifically, 2D angiographic images will be acquired with a 8 Fr catheter located in the extracranial C2-C4 segment of the internal carotid artery. 6 mLs of contrast agent will be injected at a flow rate of 4 mL/sec (standardized injection via power injector). The 2D imaging will be acquired at a rate of 4 frames per second to acquire images in anterior-posterior and lateral positions. Images will be transferred to the workstation at which syngo iFLOW software will enable quantification of the microvascular cerebral circulation time (mCCT). Post-processing via iFLOW requires 1-2 minutes. ROI selection to quantify mCCT requires approximately 2-5 minutes.
After post-MT mCCT is quantified, the catheter will be advanced to the distal M1 segment of the MCA (distal to lenticulostriates). 0.125 mg/kg (max 12.5mg) of TNK (i.e. 50% of the IV dose) will be administered via a 5-minute intraarterial infusion (using a programmable syringe pump). As described in section 3.3.1, the dose may be modified as clinical trial data become available, if the available data identify an alternative dose to be optimal.
10 minutes post-TNK, the quantitative angiographic assessment will be repeated to calculate the post-treatment mCCT. The primary objective of this trial is to quantify the change in mCCT associated with IA-TNK treatment.
Post-treatment clinical monitoring will continue as per institutional standard of care (post-MT and post-TNK monitoring). Standard of care NCCT, in addition to protocol CTA/CTP, will be performed 24 hours post-TNK to secondarily assess recanalization, reperfusion, and safety (i.e. hemorrhagic complications). Study protocol MRI of the brain will also be performed 72 hours post-TNK to quantify final infarct volume. Serial NIHSS will assess early functional outcome. Dramatic clinical recovery (DCR) will be defined as a ≥8 point improvement in NIHSS between baseline and 24 hours post-TNK. 90-day mRS will assess long-term functional outcome.
- Being tested
- intra-arterial tenecteplase administration
- Keywords
- acute ischemic stroke, ischemic stroke, large vessel occlusion, reperfusion, adjuvant thrombolysis, intra-arterial thrombolysis
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-arterial tenecteplase administrationDrug
Also called intra-arterial thrombolysis
Patients will receive a single dose of tenecteplase, administered intra-arterially after successful large vessel recanalization. The treatment will be administered via intra-arterial catheter in the distal M1 segment of the middle cerebral artery (distal to lenticulostriates).
| Study group | Role | What they receive |
|---|---|---|
| intra-arterial tenecteplase | Experimental | Patients will receive a single dose of tenecteplase, administered intra-arterially after successful large vessel recanalization. The treatment will be administered via intra-arterial catheter in the distal M1 segment of the middle cerebral artery (distal to lenticulostriates). Receives: Drug: intra-arterial tenecteplase administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microvascular cerebral circulation time (mCCT)
mCCT will be assessed by quantitative angiography, calculated as the difference between the time-to-peak of the Rolandic artery and Rolandic vein.
Measured: The change in mCCT will be calculated as mCCT immediately preceding intra-arterial tenecteplase minus the mCCT immediately following intra-arterial tenecteplase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start13 Feb 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke From Large Vessel OcclusionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Christopher Favilla, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904911
- Sponsor's protocol ID
- INTIMA-MT
- Acronym
- INTIMA-MT
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Arterial Tenecteplase to Improve the Microvascular Hemodynamics After Mechanical Thrombectomy
- ClinicalTrials.gov ID
- NCT06904911
- Acronym / sponsor ID
- INTIMA-MT / INTIMA-MT
- Keywords
- acute ischemic stroke, ischemic stroke, large vessel occlusion, reperfusion, adjuvant thrombolysis, intra-arterial thrombolysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Apr 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.
This is a prospective, single-arm, open-label study to evaluate the efficacy of intra-arterial tenecteplase in improving microvascular reperfusion following successful large vessel recanalization. Acute ischemic stroke patients with large anterior circulation large vessel occlusion will receive a single weight-based dose of intra-arterial tenecteplase after achieving successful large vessel recanalization (defined as TICI ≥ 2b) via standard of care mechanical thrombectomy. Microvascular flow will be assessed by quantitative angiography before and after the intra-arterial drug administration in order to quantify the impact of targeted thrombolysis on microvascular reperfusion. Reperfusion will be secondarily assessed with 24-hour imaging, final infarct volume will be quantified 72 hours following treatment, and functional outcome will be assessed in the short-term by the NIHSS and in the long-term by the 90-day modified Rankin Scale.
Detailed description
This is a prospective, single-arm, open-label pilot trial to evaluate the efficacy of IA-TNK in improving microvascular reperfusion following successful large vessel recanalization. Acute ischemic stroke patients will receive IA-TNK after achieving mTICI ≥ 2b recanalization via standard of care mechanical thrombectomy (MT). Microvascular flow will be assessed by quantitative angiography before and after IA-TNK to quantify the impact of targeted thrombolysis on microvascular reperfusion. Reperfusion will be secondarily assessed with 24-hour imaging. Final infarct volume will be quantified 72 hours following treatment. Functional outcome will be assessed in the short-term by the NIHSS and at 90-days by the modified Rankin Scale.
N=20 acute stroke patients will be enrolled after successful recanalization of a proximal anterior circulation LVO (internal carotid artery or first segment of the middle cerebral artery). After standard of care MT, every patient will undergo a quantitative angiographic assessment with syngo iFLOW (Siemens Healthineers). More specifically, 2D angiographic images will be acquired with a 8 Fr catheter located in the extracranial C2-C4 segment of the internal carotid artery. 6 mLs of contrast agent will be injected at a flow rate of 4 mL/sec (standardized injection via power injector). The 2D imaging will be acquired at a rate of 4 frames per second to acquire images in anterior-posterior and lateral positions. Images will be transferred to the workstation at which syngo iFLOW software will enable quantification of the microvascular cerebral circulation time (mCCT). Post-processing via iFLOW requires 1-2 minutes. ROI selection to quantify mCCT requires approximately 2-5 minutes.
After post-MT mCCT is quantified, the catheter will be advanced to the distal M1 segment of the MCA (distal to lenticulostriates). 0.125 mg/kg (max 12.5mg) of TNK (i.e. 50% of the IV dose) will be administered via a 5-minute intraarterial infusion (using a programmable syringe pump). As described in section 3.3.1, the dose may be modified as clinical trial data become available, if the available data identify an alternative dose to be optimal.
10 minutes post-TNK, the quantitative angiographic assessment will be repeated to calculate the post-treatment mCCT. The primary objective of this trial is to quantify the change in mCCT associated with IA-TNK treatment.
Post-treatment clinical monitoring will continue as per institutional standard of care (post-MT and post-TNK monitoring). Standard of care NCCT, in addition to protocol CTA/CTP, will be performed 24 hours post-TNK to secondarily assess recanalization, reperfusion, and safety (i.e. hemorrhagic complications). Study protocol MRI of the brain will also be performed 72 hours post-TNK to quantify final infarct volume. Serial NIHSS will assess early functional outcome. Dramatic clinical recovery (DCR) will be defined as a ≥8 point improvement in NIHSS between baseline and 24 hours post-TNK. 90-day mRS will assess long-term functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intra-arterial tenecteplase | Experimental | Drug: intra-arterial tenecteplase administrationPatients will receive a single dose of tenecteplase, administered intra-arterially after successful large vessel recanalization. The treatment will be administered via intra-arterial catheter in the distal M1 segment of the middle cerebral artery (distal to lenticulostriates). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient/legally authorized representative has signed the Informed Consent Form
- At least 18 years of age
- Ability to comply with the study protocol, in the investigator's judgment
- Acute ischemic stroke attributed to anterior circulation large vessel occlusion (of the internal carotid artery or first segment of the middle cerebral artery based on CTA, MRA, or catheter angiogram) being treated with mechanical thrombectomy
- NIHSS ≥ 6 at the initiation of endovascular therapy (arterial puncture)
Key exclusion criteria (32 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 (Alzheimer's patients taking lecanemab)
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR > 1.7
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 tenecteplase administrationAlso: intra-arterial thrombolysisPatients will receive a single dose of tenecteplase, administered intra-arterially after successful large vessel recanalization. The treatment will be administered via intra-arterial catheter in the distal M1 segment of the middle cerebral artery (distal to lenticulostriates). | Drug | intra-arterial tenecteplase |
Primary outcome
Change in microvascular cerebral circulation time (mCCT)
Time frame: The change in mCCT will be calculated as mCCT immediately preceding intra-arterial tenecteplase minus the mCCT immediately following intra-arterial tenecteplase
mCCT will be assessed by quantitative angiography, calculated as the difference between the time-to-peak of the Rolandic artery and Rolandic vein.
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 18 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Ischemic Stroke From Large Vessel Occlusion
Recruiting
HBO After Thrombectomy for AIS With LVO
Acute Ischemic Stroke From Large Vessel Occlusion
Not yet recruitingPhase 4
SGLT2 Inhibitor Utilization Re-perfusion Therapy
Acute Ischemic Stroke From Large Vessel Occlusion
Not yet recruitingPhase 2
Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke
Acute Ischemic Stroke From Large Vessel Occlusion
RecruitingObservational study
Prospective Registry of Endovascular Thrombectomy for eXtra-Large Ischemic Stroke
Acute Ischemic Stroke (AIS), Acute Ischemic Stroke From Large Vessel Occlusion
Not yet recruitingPhase 2
The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke
Acute Ischemic Stroke From Large Vessel Occlusion
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.
Christopher Favilla, MD principal investigator
University of Pennsylvania
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 administration in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by University of Pennsylvania 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 9 inclusion and 32 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: looking for participants now, as of the sponsor's last update on 18 Aug 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. 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?
Contact Nichole Gallatti (215-349-8651, Nichole.gallatti@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microvascular cerebral circulation time (mCCT) (time frame: The change in mCCT will be calculated as mCCT immediately preceding intra-arterial tenecteplase minus the mCCT immediately following intra-arterial tenecteplase). 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 18 Aug 2026.