Esprit BTK Post-Approval Study
Public ClinicalTrials.gov record NCT06656364. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Esprit BTK Post-Approval Study (Esprit BTK PAS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06656364
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 200 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 20, 2024
- Primary completion
- Apr 29, 2027
- Completion
- May 29, 2029
- Last update posted
- Mar 24, 2026
2024 – 2029
United States locations
- U.S. sites
- 36
- U.S. states
- 16
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth | Scottsdale | Arizona | 85258 | — |
| Pima Heart and Vascular Clinical Research | Tucson | Arizona | 85718 | — |
| UCSF Fresno | Fresno | California | 93720 | — |
| Good Samaritan Hospital | Los Angeles | California | 90017 | — |
| ClinRé 001-100 - Denver | Denver | Colorado | 80220 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32256 | — |
| Ansaarie Cardiac and Endovascular Center of Excellence | Saint Augustine | Florida | 32080 | — |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | — |
| Grady Clinical Research Center | Atlanta | Georgia | 30303 | — |
| Cardiovascular Consultants of South Georgia, LLC | Thomasville | Georgia | 31792 | — |
| SIU School of Medicine | Springfield | Illinois | 62794 | — |
| St. Vincent Hospital | Indianapolis | Indiana | 46260 | — |
| Charlton Memorial Hospital | Fall River | Massachusetts | 02720 | — |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| Sorin Medical | New York | New York | 10005 | — |
| New York University Hospital | New York | New York | 10016 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Mount Sinai Hospital | New York | New York | 10019 | — |
| New York Presbyterian Hospital-Cornell University | New York | New York | 10021 | — |
| New York-Presbyterian/Columbia University Medical Center | New York | New York | 10032 | — |
| St. Francis Hospital | Roslyn | New York | 11576 | — |
| Staten Island University Hospital - North | Staten Island | New York | 10305 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Christ Hospital | Cincinnati | Ohio | 45255 | — |
| Ascension St. John Jane Phillips | Bartlesville | Oklahoma | 74006 | — |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | — |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | — |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | — |
| Johnson City Medical Center Hospital | Johnson City | Tennessee | 37604 | — |
| Hendrick Medical Center | Abilene | Texas | 79601 | — |
| Medical City Arlington | Arlington | Texas | 76014 | — |
| University of Texas Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | — |
| Baylor All Saints Medical Center at Fort Worth | Fort Worth | Texas | 76104 | — |
| HCA Houston Healthcare Medical Center | Houston | Texas | 77004 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06656364, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06656364 live on ClinicalTrials.gov.