ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)
Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).
• Able to understand and sign an informed consent form
• Presence of clinical indication for percutaneous coronary intervention (PCI) and/or stent placement
• Subjects willing to comply with all research and follow-up requirements.
• Angiographic criteria (ONE of the following criteria MUST be met)
‣ Target lesions visually have at least moderate calcifications\*
⁃ Target lesion balloon dilatation failure
⁃ Inability of devices (microcatheters, balloons or stents) to pass through the target lesion.
• Procedural criteria
‣ All patients treated with RA with or without other forms of debulking therapy
∙ Moderate calcification is defined as radio-opacities noted only during cardiac cycle prior to contrast injection whereas severe calcification is defined as radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen.