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Esprit BTK Post-Approval Study

NCT06656364 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-25

No results posted yet for this 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.

Conditions

  • Chronic Limb-Threatening Ischemia

Interventions

DEVICE

Esprit BTK System

The Esprit BTK System is a resorbable polymeric scaffold with the everolimus drug and a resorbable polymeric coating mounted on a balloon dilatation catheter.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ramon L Varcoe, MBBS, MS, FRACS, PHD · Prince of Wales Private Hospital, Randwick, NSW, Australia

  • Sahil Parikh, MD · New York Presbyterian Hospital, New York, NY

  • Brian G Derubertis, MD · New York Presbyterian/Cornell, New York, NY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2027-04-30
Completion
2029-05-30
FDA Device
Yes

Countries

  • United States
  • Hong Kong
  • New Zealand
  • United Arab Emirates

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06656364 on ClinicalTrials.gov