🏛️ Verified NIH Record • Updated 2026-03-23

Esprit BTK Post-Approval Study (NCT06656364)

Esprit BTK Post-Approval Study (Esprit BTK PAS)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Abbott Medical Devices

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: HonorHealth — Scottsdale, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (39 Sites)

Showing the first 25 of 39 sites.

  • HonorHealth — Scottsdale, Arizona
  • Pima Heart and Vascular Clinical Research — Tucson, Arizona
  • UCSF Fresno — Fresno, California
  • Good Samaritan Hospital — Los Angeles, California
  • ClinRé 001-100 - Denver — Denver, Colorado
  • Washington Hospital Center — Washington D.C., District of Columbia
  • First Coast Cardiovascular Institute — Jacksonville, Florida
  • Ansaarie Cardiac and Endovascular Center of Excellence — Saint Augustine, Florida
  • Tallahassee Research Institute — Tallahassee, Florida
  • Grady Clinical Research Center — Atlanta, Georgia
  • Cardiovascular Consultants of South Georgia, LLC — Thomasville, Georgia
  • SIU School of Medicine — Springfield, Illinois
  • St. Vincent Hospital — Indianapolis, Indiana
  • Charlton Memorial Hospital — Fall River, Massachusetts
  • Jackson Heart Clinic — Jackson, Mississippi
  • North Mississippi Medical Center — Tupelo, Mississippi
  • Sorin Medical — New York, New York
  • New York University Hospital — New York, New York
  • NYU Langone Health — New York, New York
  • Mount Sinai Hospital — New York, New York
  • New York Presbyterian Hospital-Cornell University — New York, New York
  • New York-Presbyterian/Columbia University Medical Center — New York, New York
  • St. Francis Hospital — Roslyn, New York
  • Staten Island University Hospital - North — Staten Island, New York
  • Carolinas Medical Center — Charlotte, North Carolina

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗