Clinical Trial

Sirolimus- vs. Paclitaxel-Drug Coated Ballons in Patients With Peripheral Artery Disease

Study acronym: SIRONA
Active, Not Recruiting
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Summary
This study is a prospective, interventional, multi-center 1:1 randomized non-inferiority trial. The trial evaluates the safety and efficacy of the Magic Touch PTA sirolimus drug-coated balloon in comparison to the treatment with PTX drug-coated balloon (control device) in patients with femoropopliteal artery disease.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2020-07-16; most recent amendment 2025-12-19.
Status change: Recruiting → Active, Not Recruiting 2022-10-19
Status change: Not Yet Recruiting → Recruiting 2021-04-22
Trial Details
NCT Number NCT04475783
Lead Sponsor Jena University Hospital
Collaborators: Concept Medical Inc., Vascuscience, CoreLab Black Forest
Conditions Peripheral Artery Disease
Enrollment 478 participants
Start Date 2021-04-13
Primary Completion 2023-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-26