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Assessment of the Esprit BTK System for treating Chronic Limb-Threatening Ischemia

Esprit BTK Post-Approval Study (Esprit BTK PAS)

Not applicable Interventional Abbott Medical Devices · NCT06656364

This study is testing a new treatment for people with severe leg circulation problems to see if it helps improve their condition safely and effectively.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorAbbott Medical Devices Industry-sponsored
Locations44 sites (Scottsdale, Arizona and 43 other locations)
Trial IDNCT06656364 on ClinicalTrials.gov

What this trial studies

The Esprit BTK Post-Approval Study is a prospective, single-arm, multi-center observational study designed to evaluate the safety and effectiveness of the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System in patients with infrapopliteal lesions causing Chronic Limb-Threatening Ischemia (CLTI). Conducted at up to 50 sites across the United States, the study aims to enroll approximately 200 patients, with a focus on real-world outcomes under commercial use. Participants will be monitored for their response to the treatment, contributing valuable data to the understanding of this intervention's performance.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic Chronic Limb-Threatening Ischemia and infrapopliteal lesions.

Not a fit: Patients without infrapopliteal lesions or those with less than 70% stenosis in their target lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from Chronic Limb-Threatening Ischemia.

How similar studies have performed: Other studies have shown promise with similar interventions, but this specific approach is being evaluated in a post-approval context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* General Inclusion Criteria

  1. Subject must provide written informed consent prior to any study-specific procedures which are not considered standard of care at the site.

     1. Informed consent can be obtained up to 3 days post-procedure or prior to discharge whichever comes first.
     2. Subject, or a legally acceptable representative must provide written informed consent per site IRB/EC requirements.
  2. Subject must be at least 18 years of age.
  3. Subject has evidence of symptomatic Chronic Limb-Threatening Ischemia (CLTI) with infrapopliteal lesions.
* Anatomic Inclusion Criteria

  1. Subjects who have lesion(s) in an infrapopliteal vessel with reference vessel diameter ≥ 2.5 mm and ≤ 4.0 mm.
  2. Target lesion(s) must have ≥ 70% stenosis, per visual assessment at the time of the procedure. If needed, quantitative imaging (angiography and intravascular imaging) can be used to aid accurate sizing of the vessels.

Exclusion Criteria:

* General Exclusion Criteria

  1. Subjects who have contraindications to the Esprit BTK System per the instruction for use (IFU).
  2. Subject is currently participating in another clinical investigation.
  3. Subject is unable or unwilling to provide written consent prior to enrollment.
  4. Subject with life expectancy ≤ 1 year.
  5. Subject with an unsalvageable limb (as per physician assessment at the time of the index procedure), who is likely to get a below-the-knee amputation.
* Anatomic Exclusion Criteria

  1. Subject has in-stent restenosis in the target vessel or requires treatment with a metallic stent in the target vessel during the index procedure.
  2. Subject had been previously treated with Esprit BTK Scaffold(s).

Where this trial is running

Scottsdale, Arizona and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Limb-Threatening IschemiaABT-CIP-10519Esprit BTK SystemInfrapopliteal lesionsPost-approval study
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.