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NCT04227899 · ClinicalTrials.gov registry record · NA
LIFE-BTK Randomized Controlled Trial
A NA study of Critical Limb Ischemia (CLI), sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 261
- Enrollment target
- 20
- Study locations
NCT04227899: Active NA study of Critical Limb Ischemia (CLI), sponsored by Abbott Medical Devices.
NCT04227899 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 261 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04227899, 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
- 261 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
This endpoint was to evaluate the effectiveness of the Esprit BTK System in maintaining patency (CD-TLR and binary restenosis), and at preventing catastrophic limb events such as total vessel occlusion or major amputation. Composite of Limb Salvage and Primary Patency included freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel, binary restenosis of target lesion and clinically-driven target lesion revascularization (CD-TLR).
Conditions Studied
Interventions
- DEVICE Percutaneous Transluminal Angioplasty (PTA) Device
- DEVICE Esprit BTK Device
Study Locations (20)
California
- St. Helena Hospital - Deer Park
- Mission Cardiovascular Research Institute - Fremont
- UCSF Fresno - Fresno
- St. Joseph Hospital - Orange
Florida
- Manatee Memorial Hospital - Bradenton
- First Coast Cardiovascular Institute - Jacksonville
- Palm Vascular Centers - Miami Beach
- Tallahassee Research Institute - Tallahassee
Massachusetts
- St. Elizabeth's Medical Center - Boston
- Charlton Memorial Hospital - Russells Mills
Arizona
- Comprehensive Integrated Care - Gilbert
Arkansas
- Arkansas Heart Hospital - Little Rock
Colorado
- University of Colorado Hospital - Aurora
Connecticut
- Yale New Haven Hospital - New Haven
Georgia
- Piedmont Heart Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 261 participants |
| Start Date | 2020-08-18 |
| Est. Completion | 2027-07 |
| Phase | NA |
What the registry record for NCT04227899 still lists
NCT04227899 is an interventional study that assigns participants to a tested intervention. The registered 261 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Critical Limb Ischemia (CLI) appearing as the primary indexed condition, and to 2 interventions - of which Percutaneous Transluminal Angioplasty (PTA) Device is the first listed.
NCT04227899 names 20 study sites across 13 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04227899 about?
NCT04227899 is a clinical study titled "LIFE-BTK Randomized Controlled Trial". 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 rati...
What is the current status of trial NCT04227899?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 261 participants. The study started on 2020-08-18. Estimated completion is 2027-07.
What conditions does trial NCT04227899 study?
This clinical trial studies the following conditions: Critical Limb Ischemia (CLI).
What interventions are being tested in trial NCT04227899?
The interventions under investigation include: Percutaneous Transluminal Angioplasty (PTA) Device (DEVICE), Esprit BTK Device (DEVICE).
Who is sponsoring clinical trial NCT04227899?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04227899 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Critical Limb Ischemia (CLI)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04227899's enrollment target sits among peer trials
261 397th of 2000 higher than 1,604 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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