Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a prospective, randomized, multi-center, open label trial to compare the clinical outcomes and effectiveness of Intravascular ultrasound (IVUS) versus Fractional Flow Reserve (FFR) guided Percutaneous coronary intervention (PCI) with intermediate coronary artery lesion.
This trial is a prospective, randomized, open label, two arm designed multi-center trial. When diagnostic coronary angiogram shows that the target lesion is intermediate stenosis, IVUS and/or FFR will be performed in order to decide PCI or defer by 1:1 randomization. The patients would be followed up to 2 years clinically.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravascular ultrasound | Active Comparator |
| |
| Fractional flow reserve | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound) | Device | minimal lumen area on Intravascular ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | 1 and 2 years | |
| Myocardial infarction (MI) | 1 and 2 years | |
| Composite of cardiac death or myocardial infarction |
Not provided
Inclusion Criteria:
Clinical indication:
Angiographic indication:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sejung-Jea Tahk, MD, PhD | Ajou University Medical Center, Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung university Dongsan medical center | Daegu | South Korea | ||||
| Inje University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Pressure wire(Radi Medical Systems) | Device | Fractional flow reserve measured by pressure wire |
|
|
| 1 and 2 years |
| Target vessel revascularization (ischemia- and clinically-driven) | 1 and 2 years |
| Target lesion revascularization (ischemia- and clinically-driven) | 1 and 2 years |
| Stent thrombosis (Academic Research Consortium criteria) | 1 and 2 years |
| In-stent and in-segment late loss on angiographic follow-up | 1 year |
| In-stent and in-segment restenosis rate | 1 year |
| Incidence and angiographic pattern of restenosis | 1 year |
| Canadian Cardiovascular Society Classification status | 1 and 2 years |
| The number of anti-angina medication | 1 and 2 years |
| Incidence of percutaneous coronary intervention at intravascular ultrasound and fractional flow reserve-guided group | Baseline (day 0) |
| Major adverse cardiac events (composite of cardiac death, myocardial infarction and target vessel revascularization) | 2 years |
| Ilsan |
| South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Seoul National University Boramae Medical Center | Seoul | South Korea |
| Seoul national university hospital | Seoul | South Korea |
| Yensei University Gangnam Severance Hospital | Seoul | South Korea |
| Ajou University Medical Center | Suwon | South Korea |
| Yeonsei Univeristy Wonju College of Medicine Wonju Christion Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided