NCT04742478 ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)
| NCT ID | NCT04742478 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Heart Centre Singapore |
| Condition | Coronary Artery Calcification |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2021-03-10 |
| Primary Completion | 2024-02-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2021-03-10 with a primary completion date of 2024-02-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Khung Keong Yeo
PRINCIPAL INVESTIGATOR
Singhealth Foundation
Frequently Asked Questions
Who can join the NCT04742478 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Coronary Artery Calcification. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04742478 currently recruiting?
Yes, NCT04742478 is actively recruiting participants. Contact the research team at james.low.j.y@nhcs.com.sg for enrollment information.
Where is the NCT04742478 trial being conducted?
This trial is being conducted at Kitakyushu, Japan, Singapore, Singapore.
Who is sponsoring the NCT04742478 clinical trial?
NCT04742478 is sponsored by National Heart Centre Singapore. The principal investigator is Khung Keong Yeo at Singhealth Foundation. The trial plans to enroll 1,000 participants.