Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03338309 |
| Other study ID # |
NCT104658359911 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2017 |
| Est. completion date |
December 1, 2025 |
Study information
| Verified date |
April 2023 |
| Source |
Samsung Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
The current study sought to evaluate the clinical relevance of iFR-guided strategy in real
world clinical practice using unrestricted study population from stable angina to acute
coronary syndrome including acute ST-segment elevation myocardial infarction. Previous
abundant historical data of FFR-guided strategy will be also included as historical control
to validate the iFR-guided strategy.
Description:
In this study, the investigators will validate the clinical relevance of instantaneous wave
free ratio (iFR)-guided strategy in real world clinical practice in Korea. The 1,200 patients
who underwent iFR measurement will be prospectively enrolled at 5 centers in Republic of
Korea. In patients who were indicated revascularization after iFR measurement (iFR<0.90), iFR
pullback system (iFR Scout) and post-revascularization iFR measurement will be routinely
performed. The primary hypothesis will be tested for non-inferiority of iFR-guided strategy,
compared with FFR-guided strategy in terms of 2-year clinical outcomes. For the clinical
outcome data following FFR-guided strategy will be used from the pooled data of the DEFER-DES
trial, the 3V FFR FRIENDS registry (NCT01621438), and Korean 4-center FFR registry. Using
those data, 1200 patients will be selected from the pooled data. In addition, routine
application of iFR Scout and post-revascularization iFR measurement will enable us to
validate the clinical relevance of iFR-based prediction of acute procedural results and to
compare FFR-pullback methods.
Primary Hypothesis: The iFR-guided strategy will be non-inferior regarding patient-oriented
composite outcomes (a composite of any death, any MI, any revascularization) at 2-year,
compared with FFR-guided strategy.
Primary Outcome:
1] Patient-oriented composite outcome (POCO), defined as a composite of any death, any
myocardial infarction (MI) or any revascularization at 2-year after index procedure according
to the ARC consensus [2] Difference between Predicted post-PCI iFR value from iFR Scout and
Actual post-PCI iFR measurement
Sample Size 1,200 patients with suspected ischemic heart disease including stable angina, or
acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment
elevation MI with non-culprit stenosis enrolled at 5 centers in Republic of Korea.
1. Inclusion Criteria
① Subject must be ≥18 years
② Patients suspected with ischemic heart disease
③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70%
stenosis by visual estimation) in major epicardial coronary artery amenable to stent
implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial
ischemia.
④ Subject is able to verbally confirm understandings of risks, benefits and treatment
alternatives of receiving invasive physiologic evaluation and he/she or his/her legally
authorized representative provides
2. Exclusion criteria
- Cardiogenic shock (systolic blood pressure < 90mmHg or requiring inotropics to
maintain blood pressure > 90mmHg) ② Patients with a known hypersensitivity or
contraindication to any of the following medications: statin, ezetimibe, heparin,
aspirin, clopidogrel, prasugrel, ticagrelor
- Non-cardiac co-morbid conditions are present with life expectancy <2 year (per
site investigator's medical judgment).
- History of bleeding diathesis, known coagulopathy (including
heparin-induced thrombocytopenia) ⑤ Patients with active pathologic
bleeding ⑥ Gastrointestinal or genitourinary major bleeding within the
prior 3 months. ⑦ Target lesion located in coronary arterial bypass graft
