Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around

Description

Summary

The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation.

Official Title

Esprit BTK Post-Approval Study (Esprit BTK PAS)

Keywords

Chronic Limb-Threatening Ischemia, ABT-CIP-10519, Esprit BTK System, Infrapopliteal lesions, Post-approval study

Eligibility

Locations

  • UCSF Fresno accepting new patients
    Fresno California 93701 United States
  • Ronald Reagan UCLA Medical Center not yet accepting patients
    Los Angeles California 90095 United States
  • Good Samaritan Hospital accepting new patients
    Los Angeles California 90017 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT06656364
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated