Clinical trial Recruiting at 29 sites Observational Ages 35 and up

Observing the natural history of coronary artery disease using FFR measurements

Official title: A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention

Run by CardioVascular Research Foundation, Korea · NCT01366404 · Data updated 2026-11-12

This study is tracking around 20,000 patients with coronary artery disease to see how their condition changes over two years using special heart measurements.

More Coronary Artery Disease trials

Quick facts

Study typeObservational
Ages35 Years and up
SexAll
Enrollment20000 (estimated)
SponsorCardioVascular Research Foundation, Korea
Academic / other
Locations29 sites (Anyang and 28 other locations)
StatusRecruiting
StartedJune 2011
Main results expectedApril 2037
Study endsApril 2037
Registry record updatedMarch 20, 2026
Trial IDNCT01366404 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 35 years and older with FFR measurements indicating coronary artery stenosis.

Probably not a fit

Patients with severe coronary artery conditions, such as TIMI flow less than 3 or those with a life expectancy of less than two years, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enroll approximately 20,000 patients with Fractional Flow Reserve (FFR) measurements to evaluate the natural history of coronary lesions over a two-year period. The study will be conducted at multiple centers across Korea, focusing on clinical and imaging follow-up of participants. By tracking these patients, researchers hope to gain insights into the progression of coronary artery disease and the implications of FFR-guided interventions.

Why it matters

Potential benefit: If successful, this study could enhance understanding of coronary artery disease progression and improve patient management strategies.

How similar studies have gone: While this approach is observational, similar studies using FFR have shown promise in understanding coronary artery disease, indicating potential for valuable insights.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age 35 years and older
* FFR measurement on one and more coronary artery stenosis
* Willing and able to provide informed, written consent

Exclusion Criteria:

* Stenosis with TIMI\<3 flow
* Graft vessel
* Ejection fraction \< 30%
* Angiographic evidence of extreme tortuosity or calcified coronary vessels
* Suspected coronary spasm even after sufficient nitrate injected
* Life expectancy \<2 year
* Planned cardiac surgery or planned major non cardiac surgery
* Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Imaging study specific exclusion criteria

* visually-estimated angiographic reference segment diameter of \<2.75mm or \>4.0mm
* Inappropriate for IVUS/VH/OCT procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation

Where it's running

  • Hallym University Sacred Heart Hospital
    Anyang, South Korea
    Recruiting
  • Soon Chun Hyang University Hospital Bucheon
    Bucheon-si, South Korea
    Recruiting
  • Chungbuk National University Hospital
    Cheongju-si, South Korea
    Recruiting
  • Gangwon National Univ. Hospital
    Chuncheon, South Korea
    Recruiting
  • Daegu Catholic University Center
    Daegu, South Korea
    Recruiting
  • Keimyung University Dongsan Medical Center
    Daegu, South Korea
    Recruiting
Show 23 more locations
  • Kyungpook National university hospital
    Daegu, South Korea
    Recruiting
  • Yeungnam University Medical Center
    Daegu, South Korea
    Recruiting
  • Chungnam National University Hospital
    Daejeon, South Korea
    Recruiting
  • The Catholic University of Korea, Deajeon St.Mary's hospital
    Daejeon, South Korea
    Recruiting
  • Gangneung Asan Hospital
    Gangneung, South Korea
    Recruiting
  • Chonnam National University Hospital
    Gwangju, South Korea
    Recruiting
  • Inje University Ilsan Paik Hospital
    Ilsan, South Korea
    Recruiting
  • Dong-A Medical Center
    Pusan, South Korea
    Recruiting
  • Pusan National University Hospital
    Pusan, South Korea
    Recruiting
  • Seoul university Bundang hospital
    Seongnam, South Korea
    Recruiting
  • Asan Medical Center
    Seoul, South Korea
    Recruiting
  • Gangnam Severance Hospital
    Seoul, South Korea
    Recruiting
  • Hallym University Kangdong Sacred Heart Hospital
    Seoul, South Korea
    Recruiting
  • Korea University Anam Hospital
    Seoul, South Korea
    Recruiting
  • Korea University Guro Hospital
    Seoul, South Korea
    Recruiting
  • Kyung-Hee University Hospital at Kangdong
    Seoul, South Korea
    Recruiting
  • Seoul National University Boramae Medical Center
    Seoul, South Korea
    Recruiting
  • Seoul National University Hospital
    Seoul, South Korea
    Recruiting
  • The Catholic University of Korea, Seoul St.Mary's Hospital
    Seoul, South Korea
    Recruiting
  • The Catholic University of Korea, Yeouido St. Mary's Hospital
    Seoul, South Korea
    Recruiting
  • Ulsan University Hospital
    Ulsan, South Korea
    Recruiting
  • Wonju Severance Christian Hospital
    Wŏnju, South Korea
    Recruiting
  • Pusan National University Yangsan Hospital
    Yangsan, South Korea
    Recruiting

Study contacts

  • Principal investigator: Seung-Jung Park, MD,PhD — Asan Medical Center
  • Study coordinator: Seung-Jung Park, MD, PhD
  • Email: sjpark@amc.seoul.kr

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.