CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 9 enrolled
Drug / intervention
Esprit BTK Devicedevice
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/NCT05208905
NCT05208905N/AActive
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LIFE-BTK Pharmacokinetics (PK) Sub-study

Abbott Medical Devices·interventional·Posted Jan 26, 2022·Updated Jan 26, 2026

In Brief

A clinical study evaluating Esprit BTK Device for Critical Limb Ischemia (CLI). Active but no longer recruiting, targeting 9 participants across 5 sites in 3 countries.

Detailed Summary

LIFE-BTK PK is a prospective, single-arm, open-label, non-blinded, non-randomized sub-study of LIFE-BTK Randomized Controlled Trial (NCT04227899), that will enroll approximately 7 subjects in the United States (US) and outside the US with a maximum of 5 sites in the US. Of the 7 subjects planned to be enrolled, 4 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom drug-coated balloons (DCB) were not used; 3 subjects will be treated with Esprit BTK in below the knee artery(ies) in whom DCB were used for treatment of inflow disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Limb Ischemia (CLI)
CountriesAustralia, Taiwan, United States
Collaborators--

Timeline

N/AActive
2022202320242025202620272028
First PostedJan 26, 2022
Enrollment StartFeb 10, 2022
Primary CompletionApr 18, 2023
Study CompletionFeb 22, 2028
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.4 years ago

Interventions

Esprit BTK Devicedevice

Participants will receive Esprit BTK Device