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

Singapore Health Services (SingHealth)

Status: Enrolling

Conditions: Coronary Artery Calcification

Treatments: Procedure: Rotational Atherectomy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04742478

2020/2932

Details and patient eligibility

About

Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

Eligible subjects who underwent RA prior to PCI (with informed consent taken to join the study)

Description:

Informed consent to be obtained either prior to PCI with rotational atherectomy planned or within 48 hours after rotational atherectomy. There will be data collection of history/demographics, laboratory results, symptoms, any serious adverse events recording for this cohort as well as a telephone follow up at 12months post rotational atherectomy.

Treatment:

Procedure: Rotational Atherectomy

Eligible subjects who underwent RA prior to PCI (without informed consent taken to join the study)

Description:

Subjects that were demised or refused to give consent will fall under this cohort. The data collection of this cohort will be done through screening of in-hospital data via available local PCI database/registry.

Treatment:

Procedure: Rotational Atherectomy