The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial

Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization. Nonetheless, PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions (approximately 10-20% of all patients with CAD) have an elevated risk for adverse outcomes, including target lesion failure (TLF) and stent thrombosis (ST). Several dedicated PCI devices have been developed for treatment of severely calcified lesions. Whereas especially two of them have shown promising results in smaller, prospective studies. First, the super high-pressure NC PCI balloon (OPN™ NC, SIS Medical AG, Frauenfeld, Switzerland) has been shown to represent an effective and safe device for lesion preparation. Second, the lately introduced Shockwave intravascular lithotripsy (IVL)™ balloon catheter (Shockwave Medical, Santa Clara, CA, USA) appears to be a safe and efficient alternative device for treatment of calcified coronary lesions. However, it remains unknown, if the OPN™ NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions.

NCT Number	NCT05346068
Lead Sponsor	Luzerner Kantonsspital Collaborators: Hôpital Fribourgeois, Hamilton General Hospital
Conditions	Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Stent Restenosis, Coronary Artery Calcification
Enrollment	280 participants
Start Date	2022-11-22
Primary Completion	2025-12-31 (estimated)
Study Completion	2028-05-30 (estimated)
Updated on ClinicalTrials.gov	2024-06-18