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Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)

Influence of Total Atherosclerotic Burden Assessed by 3-vessel Fractional Flow Reserve (FFR) on the Clinical Outcomes of the Patients With Multi-vessel Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01621438
Enrollment
1136
Registered
2012-06-18
Start date
2012-05-31
Completion date
2018-09-30
Last updated
2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multivessel Coronary Artery Disease

Keywords

coronary artery, atherosclerosis, angina pectoris

Brief summary

This study will evaluate the influence of total atherosclerotic burden assessed by 3-vessel fractional flow reserve (FFR) on the clinical outcomes of the patients with multi-vessel disease. For this purpose, the clinical data of the patients with 3-vessel intermediate coronary artery disease, whose FFR was measured at all 3-vessels due to their own clinical needs, will be analyzed.

Detailed description

Primary Analysis The Primary Analysis will be performed after 2-year follow-up data will be completed. Pre-specified Subgroup Analysis The pre-specified subgroup analysis will perform after 1-year follow-up data will be completed according to the following subjects: * Concordant and discordant results between FFR and angiographic stenosis severity (patients and lesions with pre-PCI FFR will be analyzed.). * Association between total atherosclerotic burden and total ischemic burden, coronary CT angiography substudy (after 2-year follow-up will be completed). * Validation of total ischemic burden (sum of 3 vessel FFR) with Duke score, measured by treadmill test. * Comparison of clinical outcomes of deferred lesions according to pre-PCI FFR levels (Pre-PCI FFR \<0.75, 0.75-0.80, and \>0.80). * Comparison of clinical outcomes of deferred lesions according to iFR and FFR values ⑥ Prognosis of functional complete revascularization versus incomplete revascularization

Interventions

None listed

Sponsors

Samsung Medical Center
CollaboratorOTHER
Keimyung University Dongsan Medical Center
CollaboratorOTHER
Inje University
CollaboratorOTHER
Fu Wai Hospital, Beijing, China
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
CollaboratorOTHER
Guangdong Provincial People's Hospital
CollaboratorOTHER
Tokyo medical college hospital, Japan
CollaboratorUNKNOWN
Kokura Memorial Hospital
CollaboratorOTHER
Gifu Heart Center
CollaboratorOTHER
Aichi Medical University
CollaboratorOTHER
Wakayama Medical University
CollaboratorOTHER
Queen Mary Hospital, Hong Kong
CollaboratorOTHER
United Christian Hospital
CollaboratorOTHER
National University Heart Centre, Singapore
CollaboratorOTHER
National Taiwan University Hospital
CollaboratorOTHER
Nagoya Daini Nesseki Hospital
CollaboratorOTHER
Ulsan University Hospital
CollaboratorOTHER
Ajou University School of Medicine
CollaboratorOTHER
Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Subject must be at least 18 years of age. * Subject must have stenosis (\>30% by visual estimate) in all 3-epicardial coronary arteries. * FFR should be measured at all 3-vessels at the end of a procedure.

Exclusion criteria

* Depressed left ventricular systolic function (ejection fraction \< 35%) * ST-elevation myocardial infarction within 72 hours, * Prior coronary artery bypass graft surgery * Creatinine level \>= 2.0mg/dL or dependence on dialysis * Abnormal final myocardial flow (TIMI flow \< 3) * Planned bypass surgery * Failed FFR measurement * Failed intended revascularization

Design outcomes

Primary

MeasureTime frame
The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR2 years after FFR measurement

Countries

China, Japan, Singapore, South Korea, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026