The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial - A Randomized, Multicenter, Non-inferiority Comparison of Shockwave Intravascular Lithotripsy (IVL) and the OPN Non-compliant Balloon for Treatment of Calcified and Refractory Coronary Lesions
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.
• Age ≥18 years and consentable;
• Acute or chronic coronary artery disease with ischemia related symptoms (e.g. angina) and/or evidence of myocardial ischemia (e.g. FFR/ iFR, CMR, SPECT or PET-CT);
• Angiographically-proven coronary artery disease;
• Lesions in non-target vessels requiring PCI may be treated either
‣ prior to the study procedure if the procedure was unsuccessful or complicated; or
⁃ in the same session if feasible and safe for the patient, otherwise a staged PCI procedure for non-target vessels may be considered;
• Informed Consent signed by the subject.
• Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with\*:
‣ Stenosis of ≥70%;
⁃ Stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR \<0.90 or IVUS minimum lumen area ≤4.0 mm²;
• The target vessel reference diameter must be ≥2.5 mm \& ≤4.5mm;
• AND AT LEAST ONE OF THE FOLLOWING CRITERIA:
‣ Evidence of calcification at the lesion site by angiography (Grade 3), with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion,
⁃ AND/ OR by OCT, with presence of ≥270° calcium;
⁃ AND/ OR Prior attempt at PCI with inability to expand a balloon in target lesion.
∙ Annotation: Only one lesion and vessel per randomized patient may be treated according to protocol and considered for the purpose of this study. The lesion considered for the study should represent the most calcified one.
∙ The presence of any one of the following exclusion criteria will lead to the exclusion of the subject: