Study of the Natural History of FFR Guided Percutaneous Coronary Intervention
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35+
SponsorSeung-Jung Park
About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 35 years and older
FFR measurement on one and more coronary artery stenosis
Willing and able to provide informed, written consent
Disqualifiers
Stenosis with TIMI<3 flow
Graft vessel
Ejection fraction < 30%
Angiographic evidence of extreme tortuosity or calcified coronary vessels
Trial population
Patients who had FFR measurement
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20,000 Participants
are grouped into 1 trial groupGroup A: FFR
Trial outcomes
Primary outcomes
1
Target vessel failure
Time frame
2 year after index FFR measurement2
composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events
Time frame
at 2 year after index FFR measurementSecondary outcomes
1
Death (all cause and cardiac)
Time frame
at 2 year after index FFR measurement2
MI
Time frame
at 2 year after index FFR measurement3
Target vessel revascularization
Time frame
at 2 year after index FFR measurement4
Target lesion revascularization
Time frame
at 2 year after index FFR measurementSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seung-Jung Park
Lead sponsor
CardioVascular Research Foundation, Korea
Sponsor institution
CardioVascular Research Foundation, Korea
Collaborator
Abbott Medical Devices
Collaborator
Source ClinicalTrials.gov