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

Phase

N/A

Condition

Scleroderma

Treatment

N/A

Clinical Study ID

NCT04742478

2020/2932

Ages > 21
All Genders

Study 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

Inclusion Criteria:

Able to understand and sign an informed consent form
Presence of clinical indication for percutaneous coronary intervention (PCI) and/orstent 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 thetarget 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 duringcardiac cycle prior to contrast injection whereas severe calcification isdefined as radio-opacities seen without cardiac motion prior to contrastinjection, usually affecting both sides of the arterial lumen.

Exclusion

Exclusion Criteria:

Decline to give consent

Study Design

March 10, 2021

December 31, 2026

Study 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.

Connect with a study center

Kokura Memorial hospital
Kitakyushu, 802-8555
Japan
Active - Recruiting
National Heart Centre Singapore
Singapore, 169609
Singapore
Active - Recruiting

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