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NCT Number: NCT03427996

Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice

This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.

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Key information

Conditions

Atherosclerosis, Coronary Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Coronary Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Soon Chun Hyang University Hospital Bucheon, Bucheon-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 19 years old
  • Patients who received rotational atherectomy
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Exclusion criteria

  • Life expectancy <1y

Treatment and study plan

Rotational atherectomy

Procedure

Percutaneous coronary intervention with rotational atherectomy

Primary outcomes

  1. Target vessel failure (TVF)

    Time frame: 1 year

    Target vessel failure (TVF) composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target Vessel Revascularization (TVR) at 12 months after the procedure.

Secondary outcomes

  1. All death

    Time frame: 1-,6-, and 12-months, and 3-,5-years

  2. Cardiac death

    Time frame: 1-,6-, and 12-months, and 3-,5-years

  3. Myocardial infarction

    Time frame: 1-,6-, and 12-months, and 3-,5-years

  4. Composite of death or myocardial infarction

    Time frame: 1-,6-, and 12-months, and 3-,5-years

  5. Composite of cardiac death or myocardial infarction

    Time frame: 1-,6-, and 12-months, and 3-,5-years

  6. Target-lesion revascularization (TLR)

    Time frame: 1-,6-, and 12-months, and 3-,5-years

  7. Target-vessel revascularization (TVR)

    Time frame: 1-,6-, and 12-months, and 3-,5-years

  8. Stent thrombosis

    Time frame: 1-,6-, and 12-months, and 3-,5-years

    according to Academic Research Consortium (ARC) criteria

  9. Stroke

    Time frame: 1-,6-, and 12-months, and 3-,5-years

  10. Procedural success

    Time frame: 7 days

    Post-procedural diameter stenosis < 30% without death, Q-wave myocardial infarction, or urgent revascularization during the index admission

Study contacts

Contact information is provided by the study sponsor or research team.

Jung-hee Ham, RN

CONTACT

[email protected]

82230104728

Seung-jung Park, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Acronym: IRIS-ROTA

Important dates

Study start
2018
Primary completion
2029
Study completion
2034
First posted
Feb 9, 2018
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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