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

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

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Calcification
• Intervention / Treatment: Procedure: Rotational Atherectomy

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: James Low; Phone Number: 67042280; Email: james.low.j.y@nhcs.com.sg
• Study Contact Backup: Name: Phoebe Chin; Phone Number: 67042268; Email: chin.ting.ting@nhcs.com.sg

Study Locations

• Japan
  • Kitakyushu, Japan, 802-8555
    • Recruiting
    • Kokura Memorial Hospital
    • Principal Investigator: Shoichi Kuramitsu
• Singapore
  • Singapore, Singapore, 169609
    • Recruiting
    • National Heart Centre Singapore
    • Contact: James Low; Phone Number: 81285063
    • Contact: Phoebe Chin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with signed informed consent for percutaneous coronary intervention (PCI) and are eligible for calcium debulking treatment with rotational atherectomy with or without other forms of calcium debulking therapies will be enrolled into this study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Eligible subjects who underwent RA prior to PCI (with informed consent taken to join the study); 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.	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.
Eligible subjects who underwent RA prior to PCI (without informed consent taken to join the study); 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	in-hospital and at 1-year follow-up	1 year
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
Complications	Significant coronary perforation at least Type II, III or III CS based on Ellis classification	within 48 hours of procedure
Complication	no-reflow or slow flow	within 48 hours of procedure
Procedural time	Time of guide engagement to removal of guide	Duration of procedure

Collaborators and Investigators

• Sponsor: National Heart Centre Singapore
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Khung Keong Yeo, Singhealth Foundation; Principal Investigator: Shoichi Kuramitsu, Kokura Memorial Hospital

Publications and helpful links

General Publications

• 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.
• Sharma SK, Tomey MI, Teirstein PS, Kini AS, Reitman AB, Lee AC, Genereux 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Anticipated): February 29, 2024
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Rotational Atherectomy; Atherosclerotic Calcification; Medial Artery Calcification
• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis
• Other Study ID Numbers: 2020/2932

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No