NCT06656364

Esprit BTK Post-Approval Study

Esprit BTK Post-Approval Study (Esprit BTK PAS)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-10-21
• Primary completion: 2027-04-30
• Completion: 2029-05-30
• First posted: 2024-10-24
• Last updated: 2026-03-25

Locations

39 sites across 4 countries: United States, Hong Kong, New Zealand, United Arab Emirates

Regulatory

• FDA-regulated device study