Endovascular Therapy for Low NIHSS Ischemic Strokes (ENDOLOW)

STUDY OVERVIEW

This study sponsored by MedStar Health Research Institute aims to evaluate the effectiveness of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in reducing recurrent events compared to angiography-guided PCI. Despite evidence supporting IVUS use, its adoption in the U.S. remains low. This prospective, single-blind trial will randomize 2,500-3,100 subjects with complex lesions to either IVUS-guided or angiography-guided stent implantation, conducted across approximately 120 centers in the US, Canada, and Europe. Subjects will be followed for 2 years, with the study spanning about 4.5 years in total.

STUDY GOALS

The goal of this study is to evaluate the effectiveness of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) in reducing recurrent events compared to angiography-guided PCI in subjects with complex lesions.

LOCATION

El Paso, Texas: Texas Tech Health Sciences Center at El Paso

INCLUSION CRITERIA

  • Age 18 or older

  • Undergoing PCI with stent implantation for a high-risk or complex lesion, characterized by at least one of the following:

    • Chronic total occlusion

    • In-stent restenosis

    • Severe coronary artery calcification

    • Long lesion (≥ 28 mm)

    • Bifurcation lesion with a side branch ≥ 2.0 mm

  • Having stable angina, unstable angina, or NSTEMI

  • PCI performed with angiography alone or with IVUS guidance

exclusion criteria

  • Acute STEMI or cardiogenic shock

  • Use of fibrinolytic therapy within 24 hours of PCI

  • Planned staged revascularization of a target vessel

  • Stent thrombosis

  • Use of OCT during the index procedure

For more information, visit ClinicalTrials.gov.