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

NAActive, not recruitingINTERVENTIONAL
Enrollment

1,639

Participants

Timeline

Start Date

May 10, 2018

Primary Completion Date

May 10, 2022

Study Completion Date

December 31, 2025

Conditions
Coronary Artery DiseaseAtherosclerosis
Interventions
PROCEDURE

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)"

DEVICE

Drug-eluting stent

All patient will be received percutaneous coronary intervention with second generation drug-eluting stent or drug-coated balloon.

DEVICE

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."

DEVICE

Drug-coated balloon

All patient will be received percutaneous coronary intervention with second generation drug-eluting stent or drug-coated balloon.

Trial Locations (1)

06351

Samsung Medical Center, Seoul

All Listed Sponsors
lead

Samsung Medical Center

OTHER

NCT03381872 - Intravascular Imaging- Versus Angiography-Guided Percutaneous Coronary Intervention For Complex Coronary Artery Disease | Biotech Hunter | Biotech Hunter