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

Clinical inclusion criteria:

• 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 orPET-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 stagedPCI procedure for non-target vessels may be considered;

• Informed Consent signed by the subject.

Angiographic inclusion criteria:

• Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or oftheir branches) with*:

• Stenosis of ≥70%;

• Stenosis ≥50% and <70% (visually assessed) with evidence of ischemia viapositive stress test, or fractional flow reserve value ≤0.80, or iFR <0.90 orIVUS 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), withfluoroscopic radio-opacities noted without cardiac motion prior to contrastinjection involving both sides of the arterial wall in at least one locationand total length of calcium of at least 15 mm and extending partially into thetarget lesion,

• AND/ OR by OCT, with presence of ≥270° calcium;

• AND/ OR Prior attempt at PCI with inability to expand a balloon in targetlesion.

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:

Exclusion criteria:

• Patient experienced an acute STEMI or cardiogenic shock related to an acute MIwithin 2 days prior to index procedure;

• Any comorbidity or condition which may reduce compliance with this protocol,including follow-up calls/ visits (e.g. advanced dementia);

• Any medical, geographic, and/or social factor making study participation impracticalor precluding required follow-up.

• Patient is pregnant or nursing (a negative pregnancy test is required for women ofchild-bearing potential within 7 days prior to enrollment);

• Unable to take a P2Y12 inhibitor (i.e. clopidogrel, prasugrel, or ticagrelor) for atleast 6 months;

• Patient has an allergy to imaging contrast media which cannot be adequatelypre-medicated;

• Renal failure with an eGFR <30ml/min1.73m2;

• History of a stroke or transient ischemic attack (TIA) within 7 days, or any priorintracranial hemorrhage;

• Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months;

• Untreated pre-procedural hemoglobin <10g/dL or intention to refuse bloodtransfusions if one should become necessary;

• Patient has an allergy or intolerance to cobalt-chromium and/ or everolimus.

• Life expectancy of less than 1 year.

Angiographic exclusion criteria:

• Anatomy where the device or OCT catheter are unlikely to be delivered due totortuosity or other characteristics;

• Target lesion is in a coronary artery bypass graft;

• Target lesion is an in-stent restenosis (ISR);

• Flow limiting target vessel thrombus (evident on angiography or OCT);

• Definite or possible thrombus (by angiography or intravascular imaging) in thetarget vessel;

• Evidence of aneurysm in target vessel within 10 mm of the target lesion.

Of note, only qualified physicians who are investigators or a sub-investigators for the trial will assess each individual´s eligibility criteria and take the final decision to include the subject in the trial (ICH GCP 4.3.1). This decision will be documented prior to the subject receiving the first intervention.