ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)

Launched by NATIONAL HEART CENTRE SINGAPORE · Feb 5, 2021

Keywords

ClinConnect Summary

The ROVUS Asia Registry is a clinical trial that is studying a medical procedure called rotational atherectomy, which helps treat severely calcified coronary arteries. This procedure is often used when patients need a type of heart procedure called Percutaneous Coronary Intervention (PCI) or stent placement, especially when the arteries are too hard for regular devices to navigate. The trial aims to learn more about the safety and effectiveness of using this technique, either alone or alongside other treatments, to improve outcomes for patients with heavy calcium buildup in their arteries.

To participate in this trial, individuals must be able to understand and sign a consent form, have a medical reason for needing PCI, and be willing to follow the study guidelines. Key eligibility criteria include having moderate to severe calcification in the arteries or experiencing difficulties with standard treatment devices. Participants can expect to receive the rotational atherectomy procedure, along with careful monitoring and follow-up throughout the study. This trial is currently recruiting patients, and it welcomes participants of all genders aged 70 and older who meet the criteria.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• • 1. Target lesions visually have at least moderate calcifications\*
• • 2. Target lesion balloon dilatation failure
• • 3. Inability of devices (microcatheters, balloons or stents) to pass through the target lesion.
• • Procedural criteria
• • 1. 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.
• Exclusion Criteria:
• • Decline to give consent