Intra-Arterial Tenecteplase to Improve the Microvascular Hemodynamics After Mechanical Thrombectomy
University of Pennsylvania
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.
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 ho…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drugintra-arterial tenecteplase administration
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).
Location
- Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania