Status:
RECRUITING
ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)
Lead Sponsor:
National Heart Centre Singapore
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Coronary Artery Calcification
Eligibility:
All Genders
21+ years
Brief 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).
Detailed Description
This is a prospective observational multicenter cohort study of all patients with calcified coronary lesions undergoing RA in participating centres across Asia. Patients will be required to provide in...
Eligibility Criteria
Inclusion
- 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
- Decline to give consent
Key Trial Info
Start Date :
March 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04742478
Start Date
March 10 2021
End Date
December 31 2026
Last Update
April 23 2021
Active Locations (2)
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1
Kokura Memorial hospital
Kitakyushu, Japan, 802-8555
2
National Heart Centre Singapore
Singapore, Singapore, 169609