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

NCT06904911 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: INTIMA-MT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  The change in mCCT will be calculated as mCCT immediately preceding intra-arterial tenecteplase minus the mCCT immediately following intra-arterial tenecteplase

Study Arms (1)

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).

Drug: intra-arterial tenecteplase administration

Interventions

intra-arterial tenecteplase administration DRUG

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).

Also known as: intra-arterial thrombolysis

intra-arterial tenecteplase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Christopher Favilla, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nichole Gallatti

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 1, 2025
• Study Start: December 11, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Locations

US (1)