SIRONA Randomized Trial Achieves 50% Enrollment Milestone in Head-to-Head Comparison of Sirolimus vs. Paclitaxel Drug-Coated Balloons for Femoropopliteal Artery Disease
Concept Medical
Medical Device Developer
University of Fribourg
University of Fribourg (Universität Freiburg/Université de Fribourg) (swissinfo). Established in 1889, the University of Fribourg is located in the historic city of Fribourg at the foot of the Alps. As a member of the Swiss University Conference, the University of Fribourg serves as a bridge between universities in the French-speaking and German-speaking regions of Switzerland. Together with the University of Bern and the University of Neuchâtel, it forms the BENEFRI consortium of central Swiss universities, jointly conducting teaching and research activities. The University of Fribourg is the only national university in Switzerland that offers bilingual instruction (in French and German). It is also the only university in Europe that persists in using both languages for teaching and administration. Students can complete their studies and obtain bilingual diplomas by using both languages, or they may choose to study in one language to receive a monolingual diploma.The University of Fribourg comprises five faculties: Theology, Law, Economics and Social Sciences, Arts and Humanities, and Science (Mathematics and Natural Sciences), with various departments distributed across multiple institutes. Key units of the university include the Faculty of Theology and the Institute for the Study of Religion, the Medieval Institute, the International Institute of Management in Telecommunications, the Institute of Pharmacology, and the Center for Research and Documentation on Language Education (CERLE). The university boasts a diverse range of research systems across various disciplines. Currently, the student population is approximately 9,000, with international students accounting for 15% of the total.
Jena, Germany, February 11, 2022 /PRNewswire/ --Focused on Vascular Interventional Drug Delivery DevicesConcept Medical Inc., after achieving the halfway mark in trial participant enrollmentRelease the secondSIRONA RCT（WestLuoMosi and PaclitaxelDrug-Eluting Peripheral ArterialBalloonBlood VesselMoldingSurgeryUpdate on the control trial).
SIRONAIs the world's first and large-scale use of sirolimus drug-coated capsule (Magic Touch PTA- Concept Medical) and paclitaxel-coated capsules (CE-certified facility) in the treatment of lower extremity arterial occlusive disease through a randomized controlled trial. The study was initiated and driven by Dr. Ulf Teichgraber from Jena University Hospital, aiming to evaluate the safety and efficacy of sirolimus-coated capsules compared to paclitaxel-coated capsules in patients with stenosis or occlusive lesions in the superficial femoral artery and/or popliteal artery in patients with peripheral vascular disease classified as Rutherford grades 2-4.
Dr. Marianne Brodmann enrolled the 239th patient on November 23, 2021, in a forward-looking multicenter core lab randomized trial at the University of Graz. The trial aims to recruit 478 patients across 30 research centers in Germany and Austria at a 1:1 ratio, and has now reached the halfway mark. Under the centralized leadership of the principal investigator, and with the collaboration of passionate on-site researchers and operators, the trial has achieved a milestone. This indicates that despite the significant impact and disruption of the COVID-19 pandemic on healthcare services and people worldwide, the recruitment pace has not slowed.
The recent controversy over the use of paclitaxel in treating lower limb diseases has made the findings of this study critical in determining future treatment protocols, underscoring its undeniable importance. A randomized controlled trial is urgently needed, with the aim of this trial being to provide a reassessment of current treatment options through an intervention.
SIRONA Achieves 50% Recruitment Target in Just Seven Months Thanks to Principal Investigators and All Site Researchers, Especially the Key Recruiters Who Made This Encouraging Recruitment Pace Possible.Concept Medical Inc.（Magic Touch PTAThe sponsors) expressed their appreciation for their continuous contributions towards achieving this milestone. Prof. Thomas Zeller, a researcher at Universitats-Herzzentrum Freiburg in Bad Krozingen, Germany, shared his perspective on the importance of this trial as the primary recruiter:"SIRONAThe main contribution of the trial is to evaluate the effect of using an alternative anti-proliferative coating (sirolimus) on balloon catheters for the treatment of femoropopliteal artery stenosis and occlusion, in comparison with the existing paclitaxel coating. Particularly in regards to the ongoing safety discussions,SIRONAIs the firstControl trials, thus having high scientific and clinical relevance. It is reassuring that, with the recruitment status improving, the patients participating in the study generally accept this."Method."
Lead researcher Dr. Ulf Teichgräber shares his insights at the halfway point of the trial:“I believe,SIRONAWill be peripheralA Game-Changer for Arterial Diseases.”
Paclitaxel has long been the preferred treatment option, but with limited success. Sirolimus is emerging as a better choice for treating peripheral artery disease (PAD). SIRONA is the world's first and largest randomized controlled trial, set to gather evidence on the safety and efficacy of the sirolimus-coated balloon catheter - Magic Touch PTA. The U.S. Food and Drug Administration (FDA) has designated sirolimus DCB as a breakthrough device for below-the-knee PAD indications. With the positive momentum in patient recruitment, this groundbreaking trial will explore data to support and ascertain the safety and efficacy of sirolimus-coated balloons compared to paclitaxel-coated balloons (multiple studies have shown drug-coated balloons to be more effective than traditional balloon angioplasty).