Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach

Inclusion criteria

• Age ≥ 18 Years
• Chronic coronary syndrome with a clinical indication for percutaneous coronary intervention of a severely calcified lesion as defined by coronary computer tomography (CT; Agatston Score of target lesion ≥453 OR Calcium Arc >270°). The determination of calcification in the target lesion is based on native and contrast enhanced CT scans that are conducted as per clinical guidelines. The CT images must not be older than 6 months at the time of patient enrollment.
• Signed informed consent
• The patient is an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy

Exclusion criteria

• Acute ST-Elevation Acute Coronary Syndrome (STE-ACS) within 48 hours
• Cardiogenic shock
• Chronic total occlusion of the target lesion
• Glomerular filtration rate < 30 ml/min/1.73 m2
• Known presence, at the time of enrollment, of any contraindications listed in the Instructions for Use (IFU) of the investigational device:

• The OCT (optical coherence tomography) imaging catheter cannot cross
• The wire or imaging catheter cannot cross
• The target lesion is within a bypass graft or stent
• The patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy.
• The patient has angiographic evidence of thrombus
• The patient has only one open coronary vessel
• The patient has angiographic evidence of flow reducing dissection at the treatment site
• The patient has a known hypersensitivity to egg-, soy-, or peanut protein or to any of the active substances or excipients of the ViperSlide™ lubricant
• Pregnancy (assessed by clinical routine testing)
• Participation in another interventional clinical trial