Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06904911

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

Led by University of Pennsylvania · Updated on 2026-01-09

20

Participants Needed

1

Research Sites

41 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

G

Genentech, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient or legally authorized representative has signed the informed consent form
  • At least 18 years of age
  • Ability to follow the study protocol as judged by the investigator
  • Acute ischemic stroke due to large vessel blockage in the anterior circulation (internal carotid artery or first segment of middle cerebral artery) treated with mechanical thrombectomy
  • NIH Stroke Scale score of 6 or higher at the start of endovascular therapy
  • Time from stroke onset to intra-arterial tenecteplase administration less than 24 hours
  • ASPECTS score of 6 or higher on pre-thrombectomy CT imaging
  • If treatment is more than 6 hours after stroke onset, CT perfusion imaging must show a favorable mismatch profile (infarct core less than 70 mL, mismatch ratio 1.8 or greater, mismatch volume 15 mL or greater)
  • Qualifying neuroimaging must be obtained within 120 minutes before arterial puncture
Not Eligible

You will not qualify if you...

  • Current participation in another investigational drug or device study
  • Known allergy or hypersensitivity to any ingredients of tenecteplase
  • Active internal bleeding
  • Known bleeding disorders or blood clotting problems
  • Recent oral anticoagulant therapy with INR greater than 1.7
  • Use of certain oral anticoagulants (dabigatran, rivaroxaban, apixaban, edoxaban) within the last 48 hours
  • Thrombolytic treatment within the last 3 months including during the current stroke
  • Platelet count below 100,000/microliter before treatment
  • Blood glucose above 400 mg/dL or below 50 mg/dL (needs normalization before treatment)
  • Brain or spinal surgery or trauma within the last 2 months
  • Serious or terminal illness with life expectancy under 6 months
  • Stroke within the last 90 days
  • History of hemorrhagic stroke
  • Suspected septic embolus or bacterial endocarditis
  • Any condition making endovascular treatment unsafe
  • Pregnant
  • Uncontrolled high blood pressure (systolic >185 mmHg or diastolic >110 mmHg)
  • Suspected aortic dissection
  • Allergy to iodine or iodinated contrast
  • Need for dialysis or contraindication to angiogram
  • Renal failure with serum creatinine over 3.0 mg/dL or GFR below 30
  • Known brain tumor
  • Gastrointestinal bleeding in the past 21 days
  • Medical or neurological conditions that affect neurological or functional evaluations
  • Pre-stroke modified Rankin Scale score of 3 or higher
  • ASPECTS score below 6 on pre-thrombectomy CT
  • Acute brain hemorrhage or contrast leak on CT before or immediately after thrombectomy
  • Significant brain swelling with midline shift on CT before or after thrombectomy
  • Stent placement during endovascular therapy
  • Symptomatic arterial blockages in more than one brain blood vessel confirmed by imaging

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

N

Nichole Gallatti

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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