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RECRUITING NA

Esprit BTK Post-Approval Study

NCT06656364 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 200 participants
Start Date 2024-10-21
Est. Completion 2029-05-30
Phase NA

Sponsor

Abbott Medical Devices

155 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06656364

The ClinicalTrials.gov registry entry for NCT06656364 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06656364 reports 20 study locations spanning 10 distinct geographic areas — top geographies include New York, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06656364?

The interventions under investigation include: Esprit BTK System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06656364?

This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial