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LIFE-BTK Randomized Controlled Trial

NCT04227899 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2025-12-30

Study results available
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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.

Conditions

  • Critical Limb Ischemia (CLI)

Interventions

DEVICE

Esprit BTK Device

Participants will receive Esprit BTK Device

DEVICE

Percutaneous Transluminal Angioplasty (PTA) Device

Participants will receive PTA treatment

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ramon L Varcoe, MBBS, MS, FRACS, PhD · Prince of Wales Private Hospital, Randwick, NSW, Australia

  • Sahil Parikh, MD, FACC, FSCAI · New York Presbyterian Hospital, New York, NY

  • Brian DeRubertis, MD, FACS · NewYork-Presbyterian/Weill Cornell Medical Center, New York, NY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2023-08-17
Completion
2027-07-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Hong Kong
  • New Zealand
  • Singapore
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04227899 on ClinicalTrials.gov