Study of the Natural History of FFR Guided Percutaneous Coronary Intervention

NCT01366404 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seung-Jung Park

Phase

Observational

Started

2011-06

Last updated

2026-03-20

Condition(s) studied

Coronary Artery Disease

Study 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.

Eligibility

Sex

ALL

Min age

35 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Target vessel failure — 2 year after index FFR measurement
composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events — at 2 year after index FFR measurement

Trial sites (29)

Facility	City	Region	Status
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
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

More Seung-Jung Park trials in South Korea

Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice Active, not recruiting

Fractional Flow Reserve Versus Angiography for Treatment-Decision and Evaluation of Significant Left MAIN Coronary Artery Disease Recruiting

Evaluation of Effectiveness and Safety of Xience Skypoint Stents in Routine Clinical Practice Recruiting

Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice (ASAN PCI Registry) Recruiting

Asan Medical Center Myocardial Infarction Registry Recruiting

Other trials for the same condition

Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease Active, not recruiting

Impact of Potassium Competitive Acid Blockers After Percutaneous Coronary Intervention for Efficacy and Safety Outcome: Target Trial Emulation Study. Recruiting

Smart Angioplasty Research Team-Coronary CT Angiography Versus Standard Care as Follow-up Strategies in High-Risk Patients After PCI (SMART-CARE) Recruiting

IRIS-Synergy Cohort in the IRIS-DES Registry Active, not recruiting

Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01366404 on ClinicalTrials.gov ↗ ← All trials in South Korea