NCT01366404 Study of the Natural History of FFR Guided Percutaneous Coronary Intervention
| NCT ID | NCT01366404 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seung-Jung Park |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 20,000 participants |
| Start Date | 2011-06 |
| Primary Completion | 2037-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20,000 participants in total. It began in 2011-06 with a primary completion date of 2037-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Seung-Jung Park, MD, PhD
✉ sjpark@amc.seoul.krSeung-Jung Park, MD,PhD
PRINCIPAL INVESTIGATOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT01366404 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01366404 currently recruiting?
Yes, NCT01366404 is actively recruiting participants. Contact the research team at sjpark@amc.seoul.kr for enrollment information.
Where is the NCT01366404 trial being conducted?
This trial is being conducted at Anyang, South Korea, Bucheon-si, South Korea, Cheongju-si, South Korea, Chuncheon, South Korea and 11 additional locations.
Who is sponsoring the NCT01366404 clinical trial?
NCT01366404 is sponsored by Seung-Jung Park. The principal investigator is Seung-Jung Park, MD,PhD at Asan Medical Center. The trial plans to enroll 20,000 participants.