Evaluating safety and effectiveness of a procedure for heavily calcified coronary lesions
ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)
This study is testing if a special procedure called rotational atherectomy is safe and effective for people with heavily calcified coronary arteries who need a heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | National Heart Centre Singapore Academic / other |
| Locations | 2 sites (Kitakyushu and 1 other locations) |
| Trial ID | NCT04742478 on ClinicalTrials.gov |
What this trial studies
This observational multicenter cohort study aims to evaluate the safety and effectiveness of rotational atherectomy in patients with calcified coronary lesions undergoing percutaneous coronary intervention (PCI). Participants will provide informed consent for data collection, which will include demographics, clinical data, and follow-up results. The study will aggregate data from multiple centers across Asia to assess procedural outcomes and complications associated with this treatment approach. The findings will help to understand the representativeness of the data collected and the effectiveness of rotational atherectomy in this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with clinically indicated PCI and moderate to severe coronary calcification.
Not a fit: Patients who decline to give consent or do not meet the angiographic criteria for calcification will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with severe coronary calcification requiring PCI.
How similar studies have performed: Previous studies have shown that rotational atherectomy can be a safe adjunctive procedure for treating heavily calcified lesions, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kitakyushu and 1 other locations
- Kokura Memorial hospital — Kitakyushu, Japan (Recruiting)
- National Heart Centre Singapore — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Khung Keong Yeo — Singhealth Foundation
- Study coordinator: James Low
- Email: james.low.j.y@nhcs.com.sg
- Phone: 67042280
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.