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

Recruiting now

Conditions studied: Coronary Artery Calcification

In brief

Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).

Key facts

Study ID

NCT04742478

Run by

National Heart Centre Singapore

People needed

1000

Starts

2021-03-10

Expected to finish

2026-12-31

Last updated by the study team

2021-04-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Decline to give consent

Where it is running

• Kokura Memorial hospital — Kitakyushu, Japan (enrolling)
• National Heart Centre Singapore — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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