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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: intra-arterial tenecteplaseExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Pennsylvania

Lead sponsor

Genentech, Inc.

Collaborator