IRB Study Number 21-1243
Status Recruiting
Phase Phase 2
Institute Heart and Vascular Institute
Description
We invite you to take part in a research study because your doctor has determined that you have a blood vessel in your leg (one of the tibial arteries, which is located below the knee) that has become significantly narrowed by fat or calcium deposits in the wall of the artery, and it has become necessary to treat your blood vessel in your leg. The purpose of this study is to evaluate the safety and performance of the Abbott Next Generation Bioresorbable Vascular Scaffold (ESPRIT™ BTK Everolimus Eluting Bioresorbable Scaffold System) System for the treatment of narrowed arteries in critical limb ischemia (CLI), and compare the results to the current standard of care using a balloon, also called percutaneous transluminal angioplasty (PTA), the only approved therapy for the disease within United States. The Abbott ESPRIT BTK System is an investigational (experimental) device. It is not approved by the Food and Drug Administration (FDA).
Inclusion Criteria
Subject has symptomatic Critical Limb Ischemia (CLI),
Subject must be at least 18 years of age
Exclusion Criteria
Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period,
Currently enrolled in another investigational study
