ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)
National Heart Centre Singapore
1,000 participants
Mar 10, 2021
OBSERVATIONAL
Conditions
Summary
Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).
Eligibility
Inclusion Criteria10
- 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.
Exclusion Criteria1
- Decline to give consent
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Interventions
Rotational atherectomy (RA) has been the most used atherectomy modality since its first inception in1988. RA uses high speed rotation (140,000 - 180,000 rpm) to ablate inelastic plaque, resulting in debris averaging 5µm in size24. The main focus of RA in the era of DES stent has been on plaque modification rather that plaque debulking with more papers showing improved PCI success rates.
Locations(2)
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NCT04742478