Study of the Natural History of FFR Guided Percutaneous Coronary Intervention
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01366404
- Lead Sponsor
- Seung-Jung Park
- Brief Summary
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.
- Detailed Description
This is a multicenter, prospective cohort. About 20,000 patients with FFR will be enrolled at multi centres in Korea.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20000
- Age 35 years and older
- FFR measurement on one and more coronary artery stenosis
- Willing and able to provide informed, written consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events at 2 year after index FFR measurement Target vessel failure 2 year after index FFR measurement
- Secondary Outcome Measures
Name Time Method stented lesion related event including death, myocardial infarction, repeat revascularization 2 year follow-up after index FFR measurement change in IVUS-measured MLA 2 year follow-up after index FFR measurement number of anti-anginal medication prescribed 2 year follow-up after index FFR measurement change in FFR 2 year follow-up after index FFR measurement Target lesion revascularization at 2 year after index FFR measurement Any re-hospitalization with a cardiac cause 2 year follow-up after index FFR measurement cardiac death and myocardial infarction 2 year follow-up after index FFR measurement Target vessel revascularization at 2 year after index FFR measurement anginal status 2 year follow-up after index FFR measurement clinical predictors of events 2 year follow-up after index FFR measurement change in plaque composition (%necrotic core volume) in target segment 2 year follow-up after index FFR measurement Death (all cause and cardiac) at 2 year after index FFR measurement MI at 2 year after index FFR measurement stroke 2 year follow-up after index FFR measurement complication of FFR measurement 2 year follow-up after index FFR measurement change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography) 2 year follow-up after index FFR measurement change in total atheroma volume and percent atheroma volume 2 year follow-up after index FFR measurement stent thrombosis 2 year follow-up after index FFR measurement
Trial Locations
- Locations (29)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Gangwon National Univ. Hospital
🇰🇷Chuncheon, Korea, Republic of
Daegu Catholic University Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Kyungpook National university hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
The Catholic University of Korea, Deajeon St.Mary's hospital
🇰🇷Daejeon, Korea, Republic of
Gangneung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Ilsan, Korea, Republic of
Dong-A Medical Center
🇰🇷Pusan, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Seoul university Bundang hospital
🇰🇷Seongnam, Korea, Republic of
Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Kyung-Hee University Hospital at Kangdong
🇰🇷Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wonju, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of