Atherosclerosis, CoronaryIRIS-ROTANCT03427996
Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice
An observational study of Atherosclerosis, Coronary and Coronary Stenosis, run by Seung-Jung Park at 8 sites in South Korea.
Trial summary
This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atherosclerosis, Coronary, Coronary Stenosis
- What is being tested?
- Rotational atherectomy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 4 Sep 2018to 31 Dec 2034
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive percutaneous coronary intervention patients receiving rotational atherectomy
Who may be able to join
- 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.
Who cannot join
- Life expectancy <1y
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Seung-jung Park, MD contact
8 sites in 1 country
South Korea8 sites, 4 recruiting
- Recruiting
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Nae-Hee Lee, MD
Nae-Hee Lee, MD
- Recruiting
Daegu Catholic University Medical Center
Daegu
Kee-Sik Kim, MD
Kee-Sik Kim, MD
- Terminated
Chungnam National University Hospital
Daejeon
- Withdrawn
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
- Not yet recruiting
Chonnam National University Hospital
Gwangju
Young-jun Hong, MD
Young-jun Hong, MD
- Terminated
Inje University Pusan Paik Hospital
Pusan
- Terminated
Bundang CHA Hospital
Seongnam
- Recruiting
Asan Medical Center
Seoul
Seung-jung Park, MD
Seung-jung Park, MD
About this study
Official title: Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study
This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.
- Conditions
- Atherosclerosis, Coronary, Coronary Stenosis
- Being tested
- Rotational atherectomy
- Keywords
- rotational atherectomy
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational atherectomyProcedure or surgery
Percutaneous coronary intervention with rotational atherectomy
| Study group | Role | What they receive |
|---|---|---|
| Coronary disease | Not described Receives: Procedure: Rotational atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target vessel failure (TVF)
Target vessel failure (TVF) composite of death, nonfatal myocardial infarction (MI), or ischemic-driven Target Vessel Revascularization (TVR) at 12 months after the procedure.
Measured: 1 year
Secondary outcomes (10)
All death
Measured: 1-,6-, and 12-months, and 3-,5-years
Cardiac death
Measured: 1-,6-, and 12-months, and 3-,5-years
Myocardial infarction
Measured: 1-,6-, and 12-months, and 3-,5-years
Composite of death or myocardial infarction
Measured: 1-,6-, and 12-months, and 3-,5-years
Composite of cardiac death or myocardial infarction
Measured: 1-,6-, and 12-months, and 3-,5-years
Target-lesion revascularization (TLR)
Measured: 1-,6-, and 12-months, and 3-,5-years
Target-vessel revascularization (TVR)
Measured: 1-,6-, and 12-months, and 3-,5-years
Stent thrombosis
according to Academic Research Consortium (ARC) criteria
Measured: 1-,6-, and 12-months, and 3-,5-years
Stroke
Measured: 1-,6-, and 12-months, and 3-,5-years
Procedural success
Post-procedural diameter stenosis < 30% without death, Q-wave myocardial infarction, or urgent revascularization during the index admission
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start4 Sep 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis, CoronaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427996
- Sponsor's protocol ID
- AMCCV2018-02
- Acronym
- IRIS-ROTA
- Status last verified
- Dec 2025
- First submitted
- 5 Feb 2018
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Rotational Atherectomy in Routine Clinical Practice; A Multicenter, Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03427996
- Acronym / sponsor ID
- IRIS-ROTA / AMCCV2018-02
- Conditions
- Atherosclerosis, Coronary, Coronary Stenosis
- Keywords
- rotational atherectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary disease | – | Procedure: Rotational atherectomy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive percutaneous coronary intervention patients receiving rotational atherectomy
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Life expectancy <1y
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotational atherectomyPercutaneous coronary intervention with rotational atherectomy | Procedure or surgery | Coronary disease |
Primary outcome
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.
10 secondary outcomes
All death
Time frame: 1-,6-, and 12-months, and 3-,5-years
Cardiac death
Time frame: 1-,6-, and 12-months, and 3-,5-years
Myocardial infarction
Time frame: 1-,6-, and 12-months, and 3-,5-years
Composite of death or myocardial infarction
Time frame: 1-,6-, and 12-months, and 3-,5-years
Composite of cardiac death or myocardial infarction
Time frame: 1-,6-, and 12-months, and 3-,5-years
Target-lesion revascularization (TLR)
Time frame: 1-,6-, and 12-months, and 3-,5-years
Target-vessel revascularization (TVR)
Time frame: 1-,6-, and 12-months, and 3-,5-years
Stent thrombosis
Time frame: 1-,6-, and 12-months, and 3-,5-years
Stroke
Time frame: 1-,6-, and 12-months, and 3-,5-years
Procedural success
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seung-jung Park, MD contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, Coronary and Coronary Stenosis, run by Seung-Jung Park at 8 sites in South Korea.
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 3 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 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. 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 Seung-jung Park, MD (sjpark@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target vessel failure (TVF) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.