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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03427996

Acronym

IRIS-ROTA

Enrollment

500

Registered

2018-02-09

Start date

2018-09-04

Completion date

2034-12-31

Last updated

2026-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Coronary, Coronary Stenosis

Keywords

rotational atherectomy

Brief summary

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

Interventions

PROCEDURERotational atherectomy

Percutaneous coronary intervention with rotational atherectomy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Target vessel failure (TVF)	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

Measure	Time frame	Description
Cardiac death	1-,6-, and 12-months, and 3-,5-years	—
Myocardial infarction	1-,6-, and 12-months, and 3-,5-years	—
Composite of death or myocardial infarction	1-,6-, and 12-months, and 3-,5-years	—
Composite of cardiac death or myocardial infarction	1-,6-, and 12-months, and 3-,5-years	—
All death	1-,6-, and 12-months, and 3-,5-years	—
Target-vessel revascularization (TVR)	1-,6-, and 12-months, and 3-,5-years	—
Stent thrombosis	1-,6-, and 12-months, and 3-,5-years	according to Academic Research Consortium (ARC) criteria
Stroke	1-,6-, and 12-months, and 3-,5-years	—
Procedural success	7 days	Post-procedural diameter stenosis \< 30% without death, Q-wave myocardial infarction, or urgent revascularization during the index admission
Target-lesion revascularization (TLR)	1-,6-, and 12-months, and 3-,5-years	—

Countries

South Korea

Contacts

Primary ContactSeung-jung Park, MD

sjpark@amc.seoul.kr

Backup ContactJung-hee Ham, RN

cvcrc5@amc.seoul.kr82230104728

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026