SIRONA head-to-head randomised trial achieves 50% enrolment

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Concept Medical lights up NASDAQ in New York’s Times Square to celebrate the SIRONA trial achieving 50% enrolment

Concept Medical recently announced that the SIRONA randomised controlled trial (RCT; Head-to-head comparison of sirolimus versus paclitaxel drug-eluting balloon angioplasty in the femoropopliteal artery) has completed half the targeted enrolment.

According to a company press release, SIRONA is the world’s first and largest head-to-head RCT investigating the use of a sirolimus drug-coated balloon (DCB; Magic Touch PTA, Concept Medical) vs. a paclitaxel DCB (CE-certified devices) for the treatment of femoropopliteal occlusive artery disease.

The investigator-initiated and -driven trial, led by Ulf Teichgräber (Jena University Hospital, Jena, Germany) aims to evaluate the safety and efficacy of a sirolimus DCB against a paclitaxel DCB in stenosed or occluded lesions in the superficial femoral artery (SFA) and/or popliteal artery in peripheral arterial disease (PAD) patients with Rutherford class 2–4.

Marianne Brodmann (University of Graz, Graz, Austria) enrolled the 239th patient on 23 November 2021, making the trial halfway towards its target of enrolling 478 patients set to be randomised in 1:1 fashion across 30 sites in Germany and Austria.

Thomas Zeller, site investigator of Universitäts-Herzzentrum Freiburg in Bad Krozingen, Germany, expresses his thoughts on the importance of the trial: “The SIRONA trial substantially contributes to evaluating the effectiveness of an alternative antiproliferative coating (sirolimus) for balloon catheters to treat femoropopliteal stenoses and occlusions compared to the current gold standard of a paclitaxel coating. Especially with regard to the still ongoing safety discussion, SIRONA represents the first head-to-head comparison and therefore is of high scientific and clinical relevance, and is fortunately widely accepted by study patients as the recruitment status demonstrates.”

Teichgräber adds: “I am convinced that SIRONA represents a game-changing trial for PAD.”


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