Super-high-pressure non-compliant balloons for treatment of calcified coronary lesions noninferior to intravascular lithotripsy

Results from VICTORY announced at TCT 2025

2025-10-27

(Press-News.org) SAN FRANCISCO – OCTOBER 26, 2025 – New study findings show that utilizing super-high-pressure non-compliant balloons (NCB) is non-inferior to intravascular lithotripsy (IVL) balloon catheters for lesion preparation and stent expansion in severely calcified lesions during percutaneous coronary intervention (PCI).

Findings were reported today at TCT® 2025, the annual scientific symposium of the Cardiovascular Research Foundation® (CRF®). TCT is the world’s premier educational meeting specializing in interventional cardiovascular medicine.

The presence of significant coronary artery calcium affects approximately one-third of patients undergoing PCI and are a key contributor to procedural and stent failure. To address these complex lesions, a range of specialized devices have been developed, including the IVL balloon catheter which is being used with increasing frequency. The VICTORY trial was designed to compare the use of a super-high-pressure NCB to IVL for lesion preparation.

A total of 282 patients at three sites in Switzerland and Canada were randomized one to one to IVL (n=142) or the super-high-pressure NCB (n=140) for lesion preparation during PCI with drug-eluting stents. Patient and procedural characteristics were similar between both groups.

The primary endpoint was final stent expansion assessed by optical coherence tomography (OCT) determined by an independent imaging core laboratory. The NCB group achieved a median of 85.0% stent expansion compared with 84.0% in the IVL group, meeting non-inferiority (95% CI: 82.5-87.5, p<0.0001). The use of NCB 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 a number of patient subgroups. In addition, there were no significant differences in safety outcomes including coronary artery dissections, perforations, or side branch occlusions.

“This study clearly shows that utilizing a super-high-pressure non-compliant balloon is noninferior to intravascular lithotripsy for lesion preparation and stent expansion in severely calcified lesions,” said Matthias Bossard, MD, Head of the CHIP & CTO-PCI Program at Luzerner Kantonsspital Heart Center, and Assistant Professor in Health Sciences and Medicine at the University of Lucerne. “With similar safety profiles, the OPN NCB can be a feasible and faster alternative to IVL.”

The study was funded by an unrestricted research grant from SIS Medical (Frauenfeld, Switzerland). SIS Medical was not involved in the study design and trial conduct at any stage.

Dr. Bossard reported receiving grant/research support from Abbott Vascular, Cordis, Boston Scientific, OM Pharma and SIS Medical as well as consultant fees/honoraria from Abbott Vascular, Abiomed/J&J MedTech, Amgen, Astra Zeneca, Bayer, Biosensors, Boston Scientific, Cordis, Daichii, MedAlliance, Mundipharma, Novartis, Novo Nordisk, OM Pharma, Sanofi, SIS Medical and Vifor.

The results of the study were presented on Sunday, October 26, 2025, at 12:06 p.m. PT in the Main Arena (Hall A, Exhibition Level, Moscone South) at the Moscone Center during TCT 2025.

About CRF and TCT

The Cardiovascular Research Foundation (CRF) is a global leader in interventional cardiovascular medicine, driving innovation, spearheading groundbreaking research, and transforming education in the field. Through its relentless pursuit of excellence, CRF not only accelerates medical breakthroughs but also equips healthcare professionals with the tools and knowledge necessary to enhance survival rates and elevate the quality of life for millions worldwide. CRF’s centers of excellence include the CRF Skirball Center for Innovation, CRF Clinical Trials Center, CRF Center for Education, CRF Digital, TCTMD, and Structural Heart: The Journal of the Heart Team.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of CRF and the world’s premier educational meeting specializing in interventional cardiovascular medicine. Anchored in a legacy spanning over three decades, TCT is a world-class educational experience featuring disruptive innovation, scientific breakthroughs, expert-led tutorials, hands-on training, and ample opportunities for networking and collaboration.

For more information, visit www.crf.org and www.tctconference.com.

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Super-high-pressure non-compliant balloons for treatment of calcified coronary lesions noninferior to intravascular lithotripsy

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