Coronary Artery Disease Clinical Trial
— IRIS FFROfficial title:
A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention
| NCT number | NCT01366404 |
| Other study ID # | CVRF2010-09 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2011 |
| Est. completion date | April 2026 |
About 15,000 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.
| Status | Recruiting |
| Enrollment | 15000 |
| Est. completion date | April 2026 |
| Est. primary completion date | April 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 35 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 | Asan Medical Center | Seoul | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Seung-Jung Park | Abbott Medical Devices, CardioVascular Research Foundation, Korea |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Target vessel failure | 2 year after index FFR measurement | ||
| Primary | composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events | at 2 year after index FFR measurement | ||
| Secondary | Death (all cause and cardiac) | at 2 year after index FFR measurement | ||
| Secondary | MI | at 2 year after index FFR measurement | ||
| Secondary | Target vessel revascularization | at 2 year after index FFR measurement | ||
| Secondary | Target lesion revascularization | at 2 year after index FFR measurement | ||
| Secondary | Any re-hospitalization with a cardiac cause | 2 year follow-up after index FFR measurement | ||
| Secondary | cardiac death and myocardial infarction | 2 year follow-up after index FFR measurement | ||
| Secondary | stented lesion related event including death, myocardial infarction, repeat revascularization | 2 year follow-up after index FFR measurement | ||
| Secondary | stroke | 2 year follow-up after index FFR measurement | ||
| Secondary | stent thrombosis | 2 year follow-up after index FFR measurement | ||
| Secondary | anginal status | 2 year follow-up after index FFR measurement | ||
| Secondary | number of anti-anginal medication prescribed | 2 year follow-up after index FFR measurement | ||
| Secondary | complication of FFR measurement | 2 year follow-up after index FFR measurement | ||
| Secondary | clinical predictors of events | 2 year follow-up after index FFR measurement | ||
| Secondary | change in plaque composition (%necrotic core volume) in target segment | 2 year follow-up after index FFR measurement | ||
| Secondary | change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography) | 2 year follow-up after index FFR measurement | ||
| Secondary | change in total atheroma volume and percent atheroma volume | 2 year follow-up after index FFR measurement | ||
| Secondary | change in IVUS-measured MLA | 2 year follow-up after index FFR measurement | ||
| Secondary | change in FFR | 2 year follow-up after index FFR measurement |
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