Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

Recruiting now

Conditions studied: Coronary Artery Disease

In brief

About 20,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.

Key facts

Study ID

NCT01366404

Run by

Seung-Jung Park

People needed

20000

Starts

2011-06-01

Expected to finish

2037-04-01

Last updated by the study team

2026-03-20

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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