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NCT05208905 · ClinicalTrials.gov registry record · NA
LIFE-BTK PK Sub-study
A NA study of Critical Limb Ischemia (CLI), sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 9
- Enrollment target
- 5
- Study locations
NCT05208905: Active NA study of Critical Limb Ischemia (CLI), sponsored by Abbott Medical Devices.
NCT05208905 is a NA study of Critical Limb Ischemia (CLI) that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05208905, a NA study of Critical Limb Ischemia (CLI), is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 60 day period of the study after assessing at different time frames (0 minute, 10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, 30 days and 60 days post implantation).
Conditions Studied
Interventions
- DEVICE Esprit BTK Device
Study Locations (5)
Florida
- First Coast Cardiovascular Institute - Jacksonville
Massachusetts
- Charlton Memorial Hospital - South Dartmouth
Oklahoma
- Ascension St. John Jane Phillips - Bartlesville
WAUS
- Sir Charles Gairdner Hospital - Nedlands
Other
- National Taiwan University Hospital - Taipei
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2022-02-10 |
| Est. Completion | 2028-02-22 |
| Phase | NA |
What the registry record for NCT05208905 still lists
NCT05208905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Critical Limb Ischemia (CLI) appearing as the primary indexed condition, and to 1 intervention - of which Esprit BTK Device is the first listed.
NCT05208905 lists 5 locations in 5 states (Florida, Massachusetts, Oklahoma).
Frequently Asked Questions
What is clinical trial NCT05208905 about?
NCT05208905 is a clinical study titled "LIFE-BTK PK Sub-study". 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 ...
What is the current status of trial NCT05208905?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 9 participants. The study started on 2022-02-10. Estimated completion is 2028-02-22.
What conditions does trial NCT05208905 study?
This clinical trial studies the following conditions: Critical Limb Ischemia (CLI).
What interventions are being tested in trial NCT05208905?
The interventions under investigation include: Esprit BTK Device (DEVICE).
Who is sponsoring clinical trial NCT05208905?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05208905 being conducted?
This trial has 5 study locations across Florida, Massachusetts, Oklahoma, WAUS. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05208905's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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