The Flash FFR ? Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Myocardial Infarction
- Asymptomatic Ischemia
- Coronary (Artery) Disease
- Coronary Circulation
- Coronary Stenosis
- Myocardial Ischaemia
- Percutaneous Coronary Intervention
- Stable Angina Pectoris
- Unstable Angina Pectoris
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: In the Flash FFR II study, clinical outcome assessors (including the follow-up research personnel, clinical events committee (CEC), data and safety monitoring board (DSMB), and core laboratory) will be blinded to randomization arm. The data safety monitoring board (DSMB) may request unblinding of grouping information due to patient safety reasons. All the study site personnel will receive training for the blinding requirements before the trial initiating to prevent disclosure of random assignment to the follow-up personnel in any unplanned way.Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
Flash FFR ? is a prospective, multicenter, blinded, randomized, non-inferiority trial. Eligible patients with moderate coronary artery stenosis will be included in the study and randomly assigned to either caFFR-guided group or FFR-guided group. Participant caFFR or FFR will be used to guide percuta...
Flash FFR ? is a prospective, multicenter, blinded, randomized, non-inferiority trial. Eligible patients with moderate coronary artery stenosis will be included in the study and randomly assigned to either caFFR-guided group or FFR-guided group. Participant caFFR or FFR will be used to guide percutaneous coronary intervention (PCI) strategy. The rate of major cardiovascular adverse events (MACE) and the cost data will be collected during the long-term follow-up (2 years). MACE is defined as a composite of all-cause death, myocardial infarction (MI), unplanned revascularization. Clinical outcomes and cost-effectiveness will be compared between the two groups. A subgroup analysis is pre-set and included in the protocol, including age, sex, body mass index, diabetes mellitus, smoking status, mean aortic pressure (resting state), acute coronary syndrome, left ventricular ejection fraction, lesion site, lesion stenosis severity, target vessel reference diameter, small vessel lesion, blood flow velocity, PCI mode, and so on. The trial is equipped with a core laboratory. Some interesting sub-studies will be carried out, such as a comparison of laboratory and operator analysis results. If the trial results show non-inferiority, it should be noted that caFFR can bring new benefits to both operators and patients as a new index of physiological assessment of coronary artery stenosis severity with the advantages of lower cost, less risk, faster time, and less use of resources.
Tracking Information
- NCT #
- NCT04575207
- Collaborators
- Rainmed Ltd., Suzhou, China
- Investigators
- Study Chair: Yong Huo, MD Peking University First Hospital
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