CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 261 enrolled
Drug / intervention
Esprit BTK Device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04227899
NCT04227899N/AActive
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LIFE-BTK (pivotaL Investigation of saFety and Efficacy of BRS Treatment-Below The Knee) Randomized Controlled Trial

Abbott Medical Devices·interventional·Posted Jan 14, 2020·Updated Dec 30, 2025

In Brief

A clinical study evaluating Esprit BTK Device and Percutaneous Transluminal Angioplasty (PTA) Device for Critical Limb Ischemia (CLI). Active but no longer recruiting, targeting 261 participants across 50 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia (CLI)
CountriesAustralia, Hong Kong, New Zealand, Singapore, Taiwan, United States
Collaborators--

Timeline

N/AActive
20202021202220232024202520262027
First PostedJan 14, 2020
Enrollment StartAug 18, 2020
Primary CompletionAug 17, 2023
Study CompletionJul 1, 2027
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.5 years ago

Interventions

Esprit BTK Devicedevice

Participants will receive Esprit BTK Device

Percutaneous Transluminal Angioplasty (PTA) Devicedevice

Participants will receive PTA treatment