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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Atherosclerosis
• Intervention / Treatment: Procedure: Percutaneous coronary intervention for complex lesion; Device: Drug-eluting stent; Device: Intravascular imaging (IVUS or OCT); Device: Drug-coated balloon

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.

• Study Type: Interventional
• Enrollment (Actual): 1639
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject age ≥19 years old
• Coronary artery disease requiring PCI

• Patients with complex lesion

  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. Unprotected LM disease PCI (LM ostium, body, distal LM bifurcation including non-true bifurcation)
  4. Long coronary lesions (implanted stent ≥38 mm in length)
  5. Multi-vessel PCI (≥2 vessels treated at one PCI session)
  6. Multiple stents 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)
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Exclusion Criteria:

• Target lesions not amenable for PCI by operators' decision
• Cardiogenic shock (Killip class IV) at presentation
• Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
• Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
• Pregnancy or breast feeding
• Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
• Unwillingness or inability to comply with the procedures described in this protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravascular imaging arm; The choice of intravascular imaging devices such as IVUS or OCT during PCI will be left to the operator's discretion. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended. Use of intravascular imaging devices will be allowed at any step of PCI (pre-PCI, during PCI and post-PCI), but intravascular imaging evaluation after stent implantation will be mandatory.	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; Intravascular imaging arm; Angiography armDefinition of Complex LesionsTrue bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm sizeChronic total occlusion (≥3 months) as target lesionPCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)Implanted stent length ≥38mmMulti-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)Multiple stent needed (≥3 more stent per patient)In-stent restenosis lesion as target lesionSeverely calcified lesion (encircling calcium in angiography)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.
Active Comparator: Angiography arm; The PCI procedure in this group will be performed as standard procedure. After deployment of stent, stent optimization will be done based on angiographic findings. The optimization guided by angiography should meet the criteria of angiographic residual diameter stenosis less than 10% by visual estimation and the absence of flow limiting dissection (≥Type C dissection). When angiographic under-expansion of the stent is suspected, adjunctive balloon dilatation will be strongly recommended. In case of staged procedure during the same hospitalization, following the initially allocated strategy would be strongly recommended.	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; Intravascular imaging arm; Angiography armDefinition of Complex LesionsTrue bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm sizeChronic total occlusion (≥3 months) as target lesionPCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)Implanted stent length ≥38mmMulti-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)Multiple stent needed (≥3 more stent per patient)In-stent restenosis lesion as target lesionSeverely calcified lesion (encircling calcium in angiography)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: Drug-coated balloon; All patient will be received percutaneous coronary intervention with second generation drug-eluting stent or drug-coated balloon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target vessel Failure	A composite of cardiac death, target vessel MI, and clinically-driven target vessel revascularization	1-year after last patient enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	any death	1-year after last patient enrollment
Cardiac death	cardiac death	1-year after last patient enrollment
Target vessel MI without procedure-related MI	Target vessel MI without procedure-related MI	1-year after last patient enrollment
Target vessel MI with procedure-related MI	Target vessel MI with procedure-related MI	1-year after last patient enrollment
Any MI without procedure-related MI	Any MI without procedure-related MI	1-year after last patient enrollment
Any MI with procedure-related MI	Any MI with procedure-related MI	1-year after last patient enrollment
Target lesion revascularization	TLR	1-year after last patient enrollment
Target vessel revascularization	TVR	1-year after last patient enrollment
Any revascularization	clinically-driven revascularization	1-year after last patient enrollment
Total procedure time	Total procedure time during index hospitalization	Immediate after index procedure
Total amount of contrast use	Total amount of contrast use during index hospitalization	Immediate after index procedure
Incidence of contrast-induced nephropathy	CIN was defined as an increase in serum creatinine of ≥0.5mg/dL or ≥25% from baseline within 48-72 hours after contrast agent exposure	48-72 hours after index procedure
Cardiac death or target-vessel related MI	Cardiac death or target-vessel related MI	1-year after last patient enrollment
Total medical cost	Total medical cost	1-year after last patient enrollment
Target vessel failure without procedure-related MI	A composite of cardiac death, spontaneous target vessel MI, and clinically-driven target vessel revascularization	1-year after last patient enrollment
Non-target vessel related MI	Non-target vessel related MI	1-year after last patient enrollment
Stent thrombosis	definite stent thrombosis	1-year after last patient enrollment
Target vessel Failure	A composite of cardiac death, target vessel MI, and clinically-driven target vessel revascularization	4 years after last patient enrollment
Target vessel failure without procedure-related MI	A composite of cardiac death, spontaneous target vessel MI, and clinically-driven target vessel revascularization	4 years after last patient enrollment
All-cause death	any death	4 years after last patient enrollment
Cardiac death	cardiac death	4 years after last patient enrollment
Target vessel MI with procedure-related MI	Target vessel MI with procedure-related MI	4 years after last patient enrollment
Target vessel MI without procedure-related MI	Target vessel MI without procedure-related MI	4 years after last patient enrollment
Any MI with procedure-related MI	Any MI with procedure-related MI	4 years after last patient enrollment
Any MI without procedure-related MI	Any MI without procedure-related MI	4 years after last patient enrollment
Non-target vessel related MI	Non-target vessel related MI	4 years after last patient enrollment
Target lesion revascularization	TLR	4 years after last patient enrollment
Target vessel revascularization	TVR	4 years after last patient enrollment
Any revascularization	clinically-driven revascularization	4 years after last patient enrollment
Stent thrombosis	definite stent thrombosis	4 years after last patient enrollment
Bleeding (BARC definition)	BARC Classification (2,3, or 5)	4 years after last patient enrollment
Bleeding (TIMI definition)	TIMI Classification (Minimal, Minor, Major)	4 years after last patient enrollment

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Joo-Yong Hahn, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2018
• Primary Completion (Actual): May 10, 2022
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 16, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Optical Coherence Tomography; Intravascular Ultrasound; Intravascular Imaging; Complex Lesion
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
• Other Study ID Numbers: Renovate16453143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No