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Esprit BTK Post-Approval Study

Study acronym: EspritBTKPAS
StatusActive, Not Recruiting
PhaseNot applicable
Started2024-10-21
View on ClinicalTrials.gov ↗

Amendment history

2026-03-23
Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v12
Trial statusRecruiting→Active, Not Recruiting
Study sites35→39
Eligibility criteria+163 characters
[...] is currently participating in another clinical investigation that has not yet completed its primary endpoint. Subject or Legally Acceptable Representative (LAR) is unable or unwilling to provide written consent prior to [...] ct has in-stent restenosis in the target vessel or requires treatment with a metallic stent as part of a planned treatment or a bailout in the target vessel during the index procedure. Subject had been previously treated with Esprit BTK Scaffold(s) within the past 30 days in the same vessel.
Secondary endpointsdetails revised at 6 of 6 entries
2025-09-12
Study Status, Contacts/Locations v11
Study sites46→35
2025-05-28
Study Status, Contacts/Locations v10
Study sites44→46
2025-05-13
Study Status, Contacts/Locations v9
Study sitesdetails revised at 2 of 44 sites
2025-04-09
Study Status, Contacts/Locations v8
Study sites39→44
Show 7 earlier versions
2025-03-19
Study Status, Contacts/Locations v7
Study sites38→39
2025-02-24
Study Status, Contacts/Locations v6
Study sites39→38
2025-01-27
Study Status, Contacts/Locations v5
Study sites41→39
2025-01-10
Study Status, Contacts/Locations v4
Study sitesdetails revised at 5 of 41 sites
2024-12-11
Study Status, Contacts/Locations v3
Study sites35→41
2024-11-13
Study Status, Contacts/Locations v2
Study sites30→35
2024-11-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11-21→confirmed 2024-10-21
Study sites27→30
2024-10-22
Original filing
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.
Trial Details
NCT Number NCT06656364
Lead Sponsor Abbott Medical Devices
Conditions Chronic Limb-Threatening Ischemia
Enrollment 200 participants
Start Date 2024-10-21
Primary Completion 2027-04-30 (estimated)
Study Completion 2029-05-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-25