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

Recruiting

• Conditions: Coronary Artery Calcification
• Interventions: Procedure: Rotational Atherectomy

• Registration Number: NCT04742478
• Lead Sponsor: National Heart Centre Singapore

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-08
• Study Start: 2021-03-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-23
• Primary Completion: 2024-02-29
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Eligible subjects who underwent RA prior to PCI (without informed consent taken to join the study)	Rotational Atherectomy	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.
Eligible subjects who underwent RA prior to PCI (with informed consent taken to join the study)	Rotational Atherectomy	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.

Primary Outcome Measures

Name	Time	Method
Primary efficacy endpoint (Procedural success)	Duration of procedure	Procedural success defined as \< 20% residual stenosis in treated segment without on-table mortality with TIMI 3 flow.

Secondary Outcome Measures

Name	Time	Method
Death	1 year	in-hospital and at 1-year follow-up
Periprocedural myocardial infarction (MI)	within 48 hours of procedure	1. Peak CK-MB ≥ 10x ULN OR ≥ 5x ULN + new pathologic Q waves in ≥ 2 contiguous leads/ new persistent LBBB2 OR; 2. Peak Troponin T or I \> 5x ULN + new pathologic Q waves/ ischemic ECG changes
Complication	within 48 hours of procedure	no-reflow or slow flow
Complications	within 48 hours of procedure	Significant coronary perforation at least Type II, III or III CS based on Ellis classification
Procedural time	Duration of procedure	Time of guide engagement to removal of guide

Trial Locations

Locations (2)

Kokura Memorial hospital; 🇯🇵 Kitakyushu, Japan

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore