ClinicalTrials.gg
RecruitingNCT03427996IRIS-ROTAUpdated Jan 2, 2026

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

An observational study in Atherosclerosis, Coronary and Coronary Stenosis, sponsored by Seung-Jung Park. Recruiting at 8 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Seung-Jung Park · Observational

From the registry’s dates

  • Started Sep 2018; still recruiting 8 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
19 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 59 studies in Coronary Artery Disease by Seung-Jung Park — 11 open to participants now, 13 under way, none of them phase 3. Coronary Artery Disease · Seung-Jung Park.

Planned enrollment
25th of 30
500 · median 2,000
Started
2018
with 1 other
Observational
30 of 59
10 open now
Primary completion
2029-12
later than 7 of 12 live
Registered
51st of 59
by date

Among the 59 studies in Coronary Artery Disease by Seung-Jung Park, this one is the 25th largest by planned enrollment of the 30 observational ones that give a count, is one of 2 that started in 2018, is one of 30 observational ones, reaches primary completion later than 7 of the 12 other live ones, and was the 51st registered.

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

Browse Coronary Artery Disease studies →

Open to participants now

11 of the 59 studies in Coronary Artery Disease by Seung-Jung Park are open now, in 8 countries. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 11 open studies →

Who these studies take

Of the 588 Coronary Artery Disease studies recruiting now, 402 (68%) set no upper age limit and 68 (12%) stop at 75 or younger; 38 take children under 18; 47 take healthy volunteers.

This study: 19 Years and older · all sexes · no healthy volunteers.

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02

Study summary

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

03

Conditions studied

  • Atherosclerosis, Coronary
  • Coronary Stenosis

Keywords

  • rotational atherectomy
04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive percutaneous coronary intervention patients receiving rotational atherectomy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • \<1y
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Coronary disease

    Procedure: Rotational atherectomy

Interventions

  • ProcedureRotational atherectomy

    Percutaneous coronary intervention with rotational atherectomy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

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

    according to Academic Research Consortium (ARC) criteria

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

  9. Stroke

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

  10. Procedural success

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

    Time frame: 7 days

07

Study locations

3 of 8 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2018 (actual). Primary completion is estimated for Dec 2029, 135 months after the start.

Of 634 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 135 months is above that.

Counting every sponsor, half of 759 studies reached it within 40 months; a quarter within 21 and three quarters within 87.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2018
First posted
Feb 9, 2018
StartActual
Sep 4, 2018
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2034
Last update
Jan 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03427996
Lead sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
Responsible party
Seung-Jung Park (Professor, Division of Cardiology, Asan Medical Center) — Sponsor-investigator
First posted
Feb 9, 2018
Start date
Sep 4, 2018
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2034 (estimated)
Last update
Jan 2, 2026

Study contacts

Seung-jung Park, MD
Contact
sjpark@amc.seoul.kr
Jung-hee Ham, RN
Contact
cvcrc5@amc.seoul.kr
82230104728

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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