NCT05208905

LIFE-BTK PK Sub-study

LIFE-BTK Pharmacokinetics (PK) Sub-study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Limb Ischemia (CLI)

Interventions

Type	Name	Description
DEVICE	Esprit BTK Device	Participants will receive Esprit BTK Device

Timeline

• Start date: 2022-02-10
• Primary completion: 2023-04-18
• Completion: 2028-02-22
• First posted: 2022-01-26
• Last updated: 2026-01-26
• Results posted: 2026-01-26

Locations

5 sites across 3 countries: United States, Australia, Taiwan

Regulatory

• FDA-regulated device study