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

Multivessel Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01621438
• Other study ID #: H-1203-087-402
• Status: Active, not recruiting
• Phase: N/A
• First received: June 7, 2012
• Last updated: August 24, 2017
• Start date: May 2012
• Est. completion date: September 2018

Study information

• Verified date: August 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1136
• Est. completion date: September 2018
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing
China	Guandong general hospital	Guandong
China	Queen Mary Hospital, The University of Hong Kong	Hong Kong
China	United Christian Hospital	Hong Kong
China	Nanjing 1st hospital	Nanjing
China	Zhejiang No 2 hospital	Zhejiang
Japan	Gifu heart center	Gifu
Japan	Kokura memorial hospital	Kita-Kyushu
Japan	2nd Red Cross hospital	Kyoto
Japan	Aichi Medical university hospital	Nagakute
Japan	Tokyo medical college hospital	Tokyo
Japan	Wakayama medical university	Wakayama
Korea, Republic of	Keimyung University Dongsan medical center	Daegu
Korea, Republic of	Inje university Ilsan Paik hospital	Ilsan
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital, Seoul, Korea	Seoul
Korea, Republic of	Ajou university hospital	Suwon
Korea, Republic of	Ulsan university hospital	Ulsan
Singapore	National University Heart center	Singapore
Taiwan	National Taiwan University hospital	Taipei city

Sponsors (20)

Lead Sponsor

Collaborator

Seoul National University Hospital

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

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR		2 years after FFR measurement