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

Coronary Artery Calcification Clinical Trial

— ROVUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04742478
• Other study ID #: 2020/2932
• Status: Recruiting
• Start date: March 10, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2021
• Source: National Heart Centre Singapore
• Contact: James Low
• Phone: 67042280
• Email: james.low.j.y[@]nhcs.com.sg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 informed consent for data collection, including follow-up data and uploading of data on a web-based data collection platform (deidentified). Operators/ institution coordinators will fill up hardcopy or electronic (web-based) forms including patient's baseline demographics, co-morbidities, clinical data, laboratory test results, echocardiography results, coronary angiography findings with subsequent interventions performed as well as follow-up clinical and laboratory results. Note that while detailed data for individual patients will only be collected if there is informed consent, data from each institution will also be collected for aggregate data regarding procedural volume (eg. total cases with debulking therapy and specifically for ROTABLATORTM). This will give a sense of representativeness of data collected. This screening data will also include the following fields: age, gender, ethnicity, comorbidities, target vessel, prior revascularization (PCI/CABG), clinical presentation, procedural urgency, angiographic procedural details (RA and PCI) and in-hospital complication and mortality. The use of this retrospective data will require appropriate approval and will only utilize anonymized data. Only in-hospital data will be obtained and no follow up data is required from these controls. Should these data not be available in any of the participating sites, a minimum baseline demographics, procedural and inpatient outcome data with reasons for non-participation in registry should be provided for records purposes. This shall be accepted as a limitation of the study. Sub-site analysis may be performed in centres with availability of all data in this group of patients to address generalisability of the data collected.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Coronary Artery Calcification

Intervention

Procedure:
• Rotational Atherectomy
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

Country	Name	City	State
Japan	Kokura Memorial hospital	Kitakyushu
Singapore	National Heart Centre Singapore	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National Heart Centre Singapore	Boston Scientific Corporation

Countries where clinical trial is conducted

Japan,  Singapore, 

References & Publications (2)

Lee MS, Park KW, Shlofmitz E, Shlofmitz RA. Comparison of Rotational Atherectomy Versus Orbital Atherectomy for the Treatment of Heavily Calcified Coronary Plaques. Am J Cardiol. 2017 May 1;119(9):1320-1323. doi: 10.1016/j.amjcard.2017.01.025. Epub 2017 Feb 10. — View Citation

Sharma SK, Tomey MI, Teirstein PS, Kini AS, Reitman AB, Lee AC, Généreux P, Chambers JW, Grines CL, Himmelstein SI, Thompson CA, Meredith IT, Bhave A, Moses JW. North American Expert Review of Rotational Atherectomy. Circ Cardiovasc Interv. 2019 May;12(5):e007448. doi: 10.1161/CIRCINTERVENTIONS.118.007448. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy endpoint (Procedural success)	Procedural success defined as < 20% residual stenosis in treated segment without on-table mortality with TIMI 3 flow.	Duration of procedure
Secondary	Death	in-hospital and at 1-year follow-up	1 year
Secondary	Periprocedural myocardial infarction (MI)	Peak CK-MB = 10x ULN OR = 5x ULN + new pathologic Q waves in = 2 contiguous leads/ new persistent LBBB2 OR; Peak Troponin T or I > 5x ULN + new pathologic Q waves/ ischemic ECG changes	within 48 hours of procedure
Secondary	Complications	Significant coronary perforation at least Type II, III or III CS based on Ellis classification	within 48 hours of procedure
Secondary	Complication	no-reflow or slow flow	within 48 hours of procedure
Secondary	Procedural time	Time of guide engagement to removal of guide	Duration of procedure