VICTORY Compares Super-High–Pressure NC Balloon Versus IVL in PCI Treatment of Severely Calcified Lesions

October 26, 2026—New findings from the VICTORY trial showed that the use of a super-high–pressure noncompliant (NC) balloon was noninferior compared to intravascular lithotripsy (IVL) for lesion preparation and stent expansion in severely calcified lesions during percutaneous coronary intervention (PCI).

Matthias Bossard, MD, presented the VICTORY trial data at the TCT 2025 scientific symposium.

The NC balloon evaluated in the study was the OPN NC percutaneous transluminal coronary angioplasty dilatation catheter with Twin-Wall technology (SIS Medical AG). SIS, which sponsored VICTORY, announced the launch of the OPN device in the United States in early 2023.

According to TCT, the study enrolled 282 patients at three sites in Switzerland and Canada who were randomized 1:1 to IVL (n = 142) or the super-high–pressure NC balloon (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 TCT press release reported that the NC balloon group achieved a median of 85% stent expansion compared with 84% in the IVL group, meeting noninferiority (95% CI, 82.5-87.5; P < .0001). Additionally, the use of NC balloon resulted in similar rates of acute procedural (98.6% vs 97.1%) and strategy success (98.6% for both) compared with IVL. The results were consistent across a number of patient subgroups.

Also, there were no significant differences in safety outcomes including coronary artery dissections, perforations, or side branch occlusions, stated TCT.

“This study clearly shows that utilizing a super-high–pressure noncompliant balloon is noninferior to intravascular lithotripsy for lesion preparation and stent expansion in severely calcified lesions,” commented Dr. Bossard in the TCT press release. “With similar safety profiles, the OPN NC balloon can be a feasible and faster alternative to IVL.”