Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

The aim of the study is to compare clinical outcomes between intravascular imaging-guided versus angiography-guided percutaneous coronary intervention (PCI) in complex lesions.

Eligibility

Primary outcome measure(s)

• Target vessel Failure — 1-year after last patient enrollment
  A composite of cardiac death, target vessel MI, and clinically-driven target vessel revascularization

Trial sites (1)

More Samsung Medical Center trials in South Korea

Other trials for the same condition