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ACTIVE NOT RECRUITING
NCT03381872
NA

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

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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.

Official title: Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention (RENOVATE-COMPLEX-PCI)

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1639

Start Date

2018-05-10

Completion Date

2025-12-31

Last Updated

2025-08-22

Healthy Volunteers

No

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.

Locations (1)

Samsung Medical Center

Seoul, South Korea