Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
study ends around

Description

Summary

The objective of this prospective, single-blinded, randomized controlled clinical investigation is to evaluate the safety and efficacy of the everolimus eluting Esprit BTK System for the planned treatment of narrowed infrapopliteal lesions. Approximately 225 subjects will be randomized in a 2:1 ratio. The clinical investigation will be conducted at approximately 65 clinical sites in the US, Asia, Australia, and New Zealand.

Official Title

LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial

Keywords

Critical Limb Ischemia (CLI), Infrapopliteal lesions, Esprit BTK Everolimus Eluting Bioresorbable Scaffold System, Percutaneous transluminal angioplasty (PTA), ABT-CIP-10293, Chronic Limb-Threatening Ischemia, Esprit BTK Device, Percutaneous Transluminal Angioplasty (PTA) Device, Esprit BTK

Eligibility

Locations

  • UCSF Fresno
    Fresno California 93701 United States
  • Mission Cardiovascular Research Institute
    Fremont California 94538 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT04227899
Study Type
Interventional
Participants
About 261 people participating
Last Updated