NCT03381872

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,639 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After introduction of the 2nd generation drug-eluting stents (DES), the rates of device-related failure or target lesion failure such as restenosis and stent thrombosis has been markedly decreased, compared with the era of bare metal stents or 1st generation DES. Nevertheless, patients undergoing percutaneous coronary intervention (PCI) for complex lesions, for example, chronic total occlusion (CTO), left main disease, true bifurcation lesion, long lesion, multi-vessel PCI, multiple overlapping stents, or severely calcified lesions have significantly worse clinical outcomes than those with non-complex lesions. During the PCI procedure, intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are useful tools for providing information on preintervention lesion characteristics, including vulnerable plaques, lesion severity, length, and morphology; on postintervention optimal stent implantation for stent expansion, extension, and apposition; and on possible complications after stent implantation. Therefore, intravascular imaging guidance may improve clinical outcomes after complex PCI. However, although previous randomized controlled trial (RCT) and registries showed significantly lower rates of major adverse clinical events following IVUS-guided PCI compared with angiography-guided PCI, the RCTs were limited with small sample size and dealt with very selected lesion subsets such as CTO or long lesion. Moreover, it is uncertain whether OCT-guided PCI improves clinical outcomes compared with angiography-guided PCI. Meanwhile, appropriate imaging modality may differ according to patient and lesion characteristics. One of the ways to maximize the advantage of intravascular imaging is choice of intravascular imaging devices by the operator's discretion. Therefore, the current RENOVATE-COMPLEX-PCI (Randomized Controlled Trial of Intravascular Imaging Guidance versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention) is designed to investigate whether PCI under guidance of intravascular imaging devices (IVUS or OCT) chosen by operators would improve clinical outcomes compared with angiography-guided PCI in patients with complex lesions.

Conditions

• Coronary Artery Disease
• Atherosclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-10
• Primary completion: 2022-05-10
• Completion: 2025-12-31
• First posted: 2017-12-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: South Korea