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Coronary Artery CalcificationROVUSNCT04742478

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

An observational study of Coronary Artery Calcification, run by National Heart Centre Singapore at 2 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Coronary Artery Calcification
What is being tested?
Rotational Atherectomy
Type of treatment
Surgery or procedure
How many people
1,000 participants
Where
2 sitesin 2 countries
Study dates
10 Mar 2021to 31 Dec 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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)
  • Target lesions visually have at least moderate calcifications*
  • Target lesion balloon dilatation failure
Show all 10Show fewer
  • Inability of devices (microcatheters, balloons or stents) to pass through the target 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 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.

Who cannot join

  • Decline to give consent

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

James Low contact

67042280

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

Phoebe Chin contact

67042268

chin.ting.ting@nhcs.com.sg

2 sites in 2 countries

Japan1 site, 1 recruiting

  • Kokura Memorial hospital

    Kitakyushu, 802-8555

    Shoichi Kuramitsu

    Recruiting

Other trials in Japan

Singapore1 site, 1 recruiting

  • National Heart Centre Singapore

    Singapore, 169609

    James Low, 81285063

    Phoebe Chin

    Recruiting

Other trials in Singapore

About this study

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

Read the 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.

Being tested
Rotational Atherectomy
Keywords
Atherosclerotic Calcification, Medial Artery Calcification, Rotational Atherectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotational AtherectomyProcedure or surgery

    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.

Study groups in NCT04742478
Study groupRoleWhat they receive
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.
Receives: Procedure: Rotational Atherectomy
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.
Receives: Procedure: Rotational Atherectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary efficacy endpoint (Procedural success)

    Procedural success defined as < 20% residual stenosis in treated segment without on-table mortality with TIMI 3 flow.

    Measured: Duration of procedure

Secondary outcomes (5)

  1. Death

    in-hospital and at 1-year follow-up

    Measured: 1 year

  2. Periprocedural myocardial infarction (MI)

    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

    Measured: within 48 hours of procedure

  3. Complications

    Significant coronary perforation at least Type II, III or III CS based on Ellis classification

    Measured: within 48 hours of procedure

  4. Complication

    no-reflow or slow flow

    Measured: within 48 hours of procedure

  5. Procedural time

    Time of guide engagement to removal of guide

    Measured: Duration of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2021
  2. Study start10 Mar 2021
  3. Primary completion29 Feb 2024 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04742478
Sponsor's protocol ID
2020/2932
Acronym
ROVUS
Status last verified
Apr 2021
First submitted
2 Feb 2021
Last updated
23 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 28258729

  • 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.

    PubMed 31084239

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Calcification, run by National Heart Centre Singapore at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact James Low (67042280, james.low.j.y@nhcs.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary efficacy endpoint (Procedural success) (time frame: Duration of procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742478, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.

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