SIS Medical AG, a Swiss manufacturer of the Super-High-Pressure PTCA balloon catheter (OPN NC), is pleased to announce that the results of the investigator-initiated VICTORY trial were presented during the late-breaking clinical session at TCT 2025 by the Cardiovascular Research Foundation (CRF). The randomized, multi-center clinical study was designed to compare the safety and efficacy between the OPN and IVL devices for lesion preparation and optimized stent expansion in highly complex calcified coronary lesions, deploying a drug-eluting stent (DES). Coronary artery calcium affects approximately one-third of patients undergoing PCI and is a key contributor to procedural and stent failure.
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"With a similar safety profile, OPN can be a feasible and faster alternative to IVL." Dr. M. Bossard, Senior Physician at Luzerner Kantonsspital, Switzerland
A total of 282 patients at three sites in Switzerland and Canada were randomized one-to-one to IVL (n=142) and OPN (n=140). The primary endpoint was final stent expansion assessed by optical coherence tomography (OCT) determined by an independent imaging core laboratory. The OPN group achieved a median of 85.0% stent expansion compared to 84.0% in the IVL group, meeting non-inferiority (95% CI: 82.5-87.5, p<0.0001). The use of OPN resulted in similar rates of acute procedural (98.6% versus 97.1%) and strategy success (98.6% for both) compared with IVL. The results were consistent across all patient subgroups.
Additionally, OPN was equally safe to the IVL device regarding in-hospital MACE, coronary artery dissections and perforations, or side branch occlusions. “This study clearly shows that utilizing an OPN NC is non-inferior to IVL for OCT-guided lesion preparation and stent expansion in severely calcified lesions,” said Matthias Bossard, MD, Head of CHIP & CTO-PCI Program at Luzerner Kantonsspital Heart Center. “With similar safety profiles, the OPN NC can be a feasible and faster alternative to IVL.”
About the VICTORY clinical trial
VICTORY Trial – A randomized, multicenter, non-inferiority comparison of Shockwave Intravascular Lithotripsy (IVL) and the OPN non-compliant PTCA balloon for treatment of calcified and refractory coronary lesions (ClinicalTrials.gov ID NCT05346068).
About SIS Medical
SIS Medical AG, based in Frauenfeld, Switzerland, is specialized in developing, manufacturing and distributing cardiovascular products for interventional arterial diseases, offering specialty PTCA balloons for the treatment of complex calcified lesions. www.sis-medical.com
References
https://www.tctmd.com/news/trials-bolster-alternatives-intravascular-lithotripsy-calcified-lesions
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VICTORY trial: OCT-guided PCI involving lesion preparation with OPN™ balloon was non-inferior to intravascular lithotripsy on stent expansion rate for treating severely calcified coronary lesions.
Contacts
Media Contact
Dr. Thomas Kraft, Phone: +41 52 245 09 90, Email: info@sis-medical.com