Clinical Implication of 3-vessel Fractional Flow Reserve (FFR)
This trial is active, not recruiting.
|Condition||multivessel coronary artery disease|
|Sponsor||Seoul National University Hospital|
|Collaborator||Ajou University School of Medicine|
|Start date||May 2012|
|End date||March 2015|
|Trial size||1136 participants|
|Trial identifier||NCT01621438, H-1203-087-402|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Beijing, China||Fuwai hospital||no longer recruiting|
|Guandong, China||Guandong general hospital||no longer recruiting|
|Hong Kong, China||Queen Mary Hospital, The University of Hong Kong||no longer recruiting|
|Hong Kong, China||United Christian Hospital||no longer recruiting|
|Nanjing, China||Nanjing 1st hospital||no longer recruiting|
|Zhejiang, China||Zhejiang No 2 hospital||no longer recruiting|
|Gifu, Japan||Gifu heart center||no longer recruiting|
|Kita-Kyushu, Japan||Kokura memorial hospital||no longer recruiting|
|Kyoto, Japan||2nd Red Cross hospital||no longer recruiting|
|Nagakute, Japan||Aichi Medical university hospital||no longer recruiting|
|Tokyo, Japan||Tokyo medical college hospital||no longer recruiting|
|Wakayama, Japan||Wakayama medical university||no longer recruiting|
|Daegu, Korea, Republic of||Keimyung University Dongsan medical center||no longer recruiting|
|Ilsan, Korea, Republic of||Inje university Ilsan Paik hospital||no longer recruiting|
|Seoul, Korea, Republic of||Seoul National University Hospital, Seoul, Korea||no longer recruiting|
|Suwon, Korea, Republic of||Ajou university hospital||no longer recruiting|
|Ulsan, Korea, Republic of||Ulsan university hospital||no longer recruiting|
|Singapore, Singapore||National University Heart center||no longer recruiting|
|Taipei city, Taiwan||National Taiwan University hospital||no longer recruiting|
The rate of the composite of major adverse cardiac events (MACE: cardiac death, myocardial infarction, revascularization) at 2 years per 3-vessel FFR
time frame: 2 years after FFR measurement
Male or female participants of any age.
- 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.
- 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
|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|
|Principal investigator||Bon-Kwon Koo, MD|
|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).|
Call for more information