Recruiting

Phase 2

TenecteplaseIntra-Arterial Tenecteplase to Improve the Microvascular Hemodynamics After Mechanical Thrombectomy

Sponsor:

University of Pennsylvania

Code:

NCT06904911

Conditions

Acute Ischemic Stroke From Large Vessel Occlusion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

intra-arterial tenecteplase administration

Study Details

Brief 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. 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.

Conditions

Acute Ischemic Stroke From Large Vessel Occlusion

Study ID

NCT06904911

Start date

Feb 13, 2026

Status verified date

Aug, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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
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.

Exclusion Criteria:

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)
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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: intra-arterial tenecteplase

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).

Interventions

intra-arterial tenecteplase administration

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 ]

Central Contacts and Locations

Central contacts

Nichole Gallatti

215-349-8651 Nichole.gallatti@pennmedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Nichole Gallatti

215-349-8651 nichole.gallatti@pennmedicine.upenn.edu

Principal Investigator:

Christopher Favilla, M.D

More Information

Sponsor

University of Pennsylvania

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

acute ischemic stroke
ischemic stroke
large vessel occlusion
reperfusion
adjuvant thrombolysis
intra-arterial thrombolysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-08-18.