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

NCT ID: NCT04742478

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2026-12-31

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.

Conditions

Coronary Artery Calcification

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Rotational Atherectomy

Intervention Type: PROCEDURE

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.

Rotational Atherectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

National Heart Centre Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khung Keong Yeo

Role: PRINCIPAL_INVESTIGATOR

Singhealth Foundation

Shoichi Kuramitsu

Role: PRINCIPAL_INVESTIGATOR

Kokura Memorial Hospital

Locations

Kokura Memorial hospital

Kitakyushu, , Japan

Site Status: RECRUITING

National Heart Centre Singapore

Singapore, , Singapore

Site Status: RECRUITING

Countries

Japan; Singapore

Central Contacts

James Low

Role: CONTACT

james.low.j.y@nhcs.com.sg

67042280

Phoebe Chin

Role: CONTACT

chin.ting.ting@nhcs.com.sg

67042268

Facility Contacts

James Low

Role: primary

81285063

Phoebe Chin

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 28258729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31084239 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2020/2932

Identifier Type: -

Identifier Source: org_study_id