ischemic heart disease
Conditions
Interventions
iFR-based decision making group, (predicted post PCI iFR >
0.89)
control group, IVUS based decision (visually estimated percent plaque area <
50%)
Sponsors
Tsukazaki Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: directional coronary atherectomy (DCA) target lesion was selected as following criteria; native coronary artery lesion located in non-ostial left main trunk or right coronary artery, ostium of the left anterior descending or left circumflex artery, or a major bifurcation located at the proximal left anterior descending or left circumflex symptomatic angina or objective signs of ischemia (stress electrocardiogram, myocardial perfusion imaging, fractional flow reserve, or instantaneous wave-free ratio) lesion stenosis 75%< and <100%, and 15 mm or less in length by visual estimation de novo lesion or plain old balloon angioplasty restenotic lesion vessel suitable for transfemoral approach (DCA device size 7 French or more) age between 20 and 85-years-old signed written informed consent The revascularization (with or without a stent) of distal non-target major vessel lesion in proximity to the target lesion was permitted during the index procedure, to achieve iFR-based endpoint (iFR>0.89) in iFR group, or treat IVUS detected severe stenosis (minimum lumen diameter<2.0mm, minimum lumen area<4.0 square millimeter) in control group. Bailout stenting for target lesion was performed only in cases of a suboptimal result, defined as flow-limiting dissection and/or a persistent residual stenosis refractory to optimal directional coronary atherectomy and balloon dilation. It was reported as "Bailout stenting" separately from the acute phase complications (described below). (Acute complications were defined as intravascular ultrasound detected deep cut (either resection of media or adventitia) and/or coronary perforation in the target lesion, and adequately treated by watchful waiting, perfusion PTCA, stents, covered-stents, or emergency CABG.)
Exclusion criteria
Exclusion criteria: culprit lesion for acute myocardial infarction within 2 weeks Aorto-ostial lesion presence of thrombus at the lesion stent or directional coronary atherectomy restenotic lesion angulated lesion >60 degree diffuse disease significant tortuosity severe peripheral vascular disease markedly calcified lesion by angiography and/or superficial calcium >180 degree detected by IVUS attenuated plaque (>180 degree) detected by IVUS contraindication or intolerance to paclitaxel, aspirin, thienopyridines, or contrast media, and concomitant significant medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Protcol 1, acute phase complications (intravascular ultrasound detected deep cut (either resection of media or adventitia) and/or coronary perforation) and 3 month major adverse cardiac event (MACE) including all-cause death, non-fatal myocardial infarction, clinically driven target lesion revascularization (TLR) defined as any repeat percutaneous coronary intervention or aortocoronary bypass surgery and a diameter stenosis >50% associated with symptoms or objective signs of ischemia (stress electrocardiogram, myocardial perfusion imaging, fractional flow reserve and instantaneous wave-free ratio) Protcol 2, acute phase complications and 1 year MACE Protcol 3, acute phase complications and long term MACE (>1 year) | — |
Secondary
| Measure | Time frame |
|---|---|
| bailout stenting for flow-limiting dissection, late lumen loss, binary restenosis, follow-up iFR, follow-up focal delta-iFR (treated lesion), procedure time, clinically driven target vessel revascularization | — |
Countries
Japan
Contacts
Public ContactArata Hagikura
Tsukazaki Hospital Department of Cardiology
Outcome results
None listed