1,639
Participants
Start Date
May 10, 2018
Primary Completion Date
May 10, 2022
Study Completion Date
December 31, 2025
Percutaneous coronary intervention for complex lesion
"In patients who have complex coronary lesions, PCI will performed using intravascular imaging or angiography only according to the allocated arms~1. Intravascular imaging arm~2. Angiography arm~ * Definition of Complex Lesions~ 1. True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size~ 2. Chronic total occlusion (≥3 months) as target lesion~ 3. PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)~ 4. Implanted stent length ≥38mm~ 5. Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)~ 6. Multiple stent needed (≥3 more stent per patient)~ 7. In-stent restenosis lesion as target lesion~ 8. Severely calcified lesion (encircling calcium in angiography)~ 9. Ostial coronary lesion (LAD, LCX, RCA)"
Drug-eluting stent
All patient will be received percutaneous coronary intervention with second generation drug-eluting stent or drug-coated balloon.
Intravascular imaging (IVUS or OCT)
"IVUS Reference site: Largest lumen, Plaque burden \<50% Stent sizing: By measuring vessel diameter (external elastic membrane) at proximal and distal reference sites. The averaged value of the proximal and distal reference external elastic membrane diameter will be used as stent diameter~OCT Reference site: Most normal looking segment, No Lipidic plaque Stent sizing: \[1\] By measuring vessel diameter at the distal reference sites (in case of ≥180° of the external elastic membrane can be identified). In this case, stent diameter will be determined using mean external elastic membrane diameter at the distal reference, rounded down to the nearest 0.25 mm.~\[2\] By measuring lumen diameter at the distal reference sites (in case of ≥180° of the external elastic membrane cannot be identified). In this case, stent diameter will be determined using mean lumen diameter at the distal reference, rounded up to the nearest 0.25 mm."
Drug-coated balloon
All patient will be received percutaneous coronary intervention with second generation drug-eluting stent or drug-coated balloon.
Samsung Medical Center, Seoul
Samsung Medical Center
OTHER