Clinical Trial

Trial to Assess the Safety and Efficacy of Sirolimus-Coated Balloon vs. Uncoated Standard Angioplasty for the Treatment of Below-the-knee Peripheral Arterial Disease

Study acronym: LIMES
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated December 26, 2025 (before its estimated April 17, 2026 completion). Its status may not reflect the trial's current state.
Summary
This study is a prospective, interventional, multicenter 1:1 randomized trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with POBA (control device) in patients with advanced infrapopliteal artery disease.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2021-02-25; most recent amendment 2025-12-19.
Status change: Recruiting → Active, Not Recruiting 2025-12-19
Status change: Not Yet Recruiting → Recruiting 2022-04-05
Trial Details
NCT Number NCT04772300
Lead Sponsor Jena University Hospital
Collaborators: Concept Medical Inc., Vascuscience, CoreLab Black Forest, Center for Clinical Studies Jena
Conditions Peripheral Artery Disease
Enrollment 230 participants
Start Date 2022-02-10
Primary Completion 2026-04-17 (estimated)
Study Completion 2028-11-17 (estimated)
Updated on ClinicalTrials.gov 2025-12-26