Concept Medical has announced the completion of patient enrolment in the SIRONA trial. According to the company, this is the world’s first and the largest head-to-head randomised controlled trial (RCT) investigating the use of a sirolimus drug-coated balloon (DCB; Magic Touch PTA) versus paclitaxel DCB angioplasty for the treatment of peripheral arterial disease (PAD) in the femoropopliteal vessel segment.
The prospective, multicentre, head-to-head, core lab adjudicated RCT enrolled a total of 480 patients across 28 sites in Germany and Austria. The target patient was enrolled on 23 September at Hanusch Hospital (Vienna, Austria) by Martin Werner and team.
Ulf Teichgräber (Jena University Hospital, Jena, Germany) states: “As coordinating PI [principal investigator] I am thrilled to work with 28 highly dedicated and motivated study sites that have managed to complete enrolment much earlier than expected. SIRONA represents a breakthrough head-to-head RCT with the potential to usher in a new era of sirolimus DCBs in PAD to replace an old technology.”
Concept Medical notes in a press release that, under the leadership of Thomas Zeller, the University Heart Center Bad Krozingen (Bad Krozingen, Germany) enrolled the highest number of patients in the study. “It is exciting that enrolment into the first head-to-head comparative study between a sirolimus-coated DCB and a variety of marketed paclitaxel-coated DCBs for the femoropopliteal indication could be finished in such a short time. The study has sufficient size and the power to demonstrate if there is at least equivalent performance between the Magic Touch DCB and a range of paclitaxel coated DCB and if so, if there are potential lesions which may even benefit from the use of a sirolimus coated DCB,” Zeller remarks.