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NCT06656364 · ClinicalTrials.gov registry record · NA
Esprit BTK Post-Approval Study
A NA study of Chronic Limb-Threatening Ischemia, sponsored by Abbott Medical Devices.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06656364: Recruiting NA study of Chronic Limb-Threatening Ischemia, sponsored by Abbott Medical Devices.
NCT06656364 is a NA study of Chronic Limb-Threatening Ischemia that is actively recruiting participants, run by Abbott Medical Devices. The registered enrollment target is 200 participants, above the 162-participant average among 9 other Chronic Limb-Threatening Ischemia trials with a reported enrollment target (23% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06656364, a NA study of Chronic Limb-Threatening Ischemia, is actively recruiting participants, sponsored by Abbott Medical Devices.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threatening Ischemia) in a real-world setting. The clinical investigation will be conducted at up to 50 sites in the United States (US) and additional sites may be added outside of the US (OUS). Approximately 200 patients with a minimum of 50% of patients in the US will be registered in the clinical investigation.
Primary Outcome
This effectiveness endpoint was chosen because it allows to assess whether Esprit BTK is effective at maintaining patency (CD-TLR).
Conditions Studied
Interventions
- DEVICE Esprit BTK System
Study Locations (20)
New York
- New York University Hospital - New York
- Mount Sinai Hospital - New York
- New York Presbyterian Hospital-Cornell University - New York
- New York-Presbyterian/Columbia University Medical Center - New York
- St. Francis Hospital - Roslyn
Florida
- First Coast Cardiovascular Institute - Jacksonville
- Ansaarie Cardiac and Endovascular Center of Excellence - Saint Augustine
- Tallahassee Research Institute - Tallahassee
Arizona
- HonorHealth - Scottsdale
- Pima Heart and Vascular Clinical Research - Tucson
California
- UCSF Fresno - Fresno
- Good Samaritan Hospital - Los Angeles
Georgia
- Grady Clinical Research Center - Atlanta
- Archbold Medical Center - Thomasville
Mississippi
- Jackson Heart Clinic - Jackson
- North Mississippi Medical Center - Tupelo
District of Columbia
- Washington Hospital Center - Washington D.C.
Illinois
- SIU School of Medicine - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-10-21 |
| Est. Completion | 2029-05-30 |
| Phase | NA |
What NCT06656364 shows while recruiting
NCT06656364 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 162-participant average among 9 other Chronic Limb-Threatening Ischemia trials with a reported enrollment target (23% higher).
The record links to 1 condition, with Chronic Limb-Threatening Ischemia appearing as the primary indexed condition, and to 1 intervention - of which Esprit BTK System is the first listed.
NCT06656364 names 20 study sites across 10 states, led by New York, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06656364 about?
NCT06656364 is a clinical study titled "Esprit BTK Post-Approval Study". The Esprit BTK PAS is a prospective, single-arm, multi-center observational study to assess the continued safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System under commercial use, in patients with diseased infrapopliteal lesions causing CLTI (Chronic Limb-Threat...
What is the current status of trial NCT06656364?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2024-10-21. Estimated completion is 2029-05-30.
What conditions does trial NCT06656364 study?
This clinical trial studies the following conditions: Chronic Limb-Threatening Ischemia.
What interventions are being tested in trial NCT06656364?
The interventions under investigation include: Esprit BTK System (DEVICE).
Who is sponsoring clinical trial NCT06656364?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06656364 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Limb-Threatening Ischemia
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 NCT06656364's enrollment target sits among peer trials
200 4th of 9 higher than 6 of 9 other Chronic Limb-Threatening Ischemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Limb-Threatening Ischemia 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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