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

NCT03381872 | Active Not Recruiting DMC

• 1 other identifier: Renovate16453143
• Study Type: interventional
• Target: 1,639
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Atherosclerosis

Keywords

Intravascular Imaging; Intravascular Ultrasound; Optical Coherence Tomography; Complex Lesion; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

• Target vessel Failure

  A composite of cardiac death, target vessel MI, and clinically-driven target vessel revascularization

  1-year after last patient enrollment

Secondary Outcomes (32)

• Target vessel failure without procedure-related MI

  1-year after last patient enrollment

• Cardiac death or target-vessel related MI

  1-year after last patient enrollment

• All-cause death

  1-year after last patient enrollment

• Cardiac death

  1-year after last patient enrollment

• Target vessel MI with procedure-related MI

  1-year after last patient enrollment

Study Arms (2)

Intravascular imaging arm

ACTIVE COMPARATOR

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; Device: Drug-eluting stent; Device: Intravascular imaging (IVUS or OCT); Device: Drug-coated balloon

Angiography arm

ACTIVE COMPARATOR

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; Device: Drug-eluting stent; Device: Drug-coated balloon

Interventions

Percutaneous coronary intervention for complex lesion PROCEDURE

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)

Angiography arm; Intravascular imaging arm

Drug-eluting stent DEVICE

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

Angiography arm; Intravascular imaging arm

Intravascular imaging (IVUS or OCT) DEVICE

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.

Intravascular imaging arm

Drug-coated balloon DEVICE

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

Angiography arm; Intravascular imaging arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject age ≥19 years old
• Coronary artery disease requiring PCI
• Patients with complex lesion
• True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
• Chronic total occlusion (≥3 months) as target lesion
• Unprotected LM disease PCI (LM ostium, body, distal LM bifurcation including non-true bifurcation)
• Long coronary lesions (implanted stent ≥38 mm in length)
• Multi-vessel PCI (≥2 vessels treated at one PCI session)
• Multiple stents needed (≥3 more stent per patient)
• In-stent restenosis lesion as target lesion
• Severely calcified lesion (encircling calcium in angiography)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (12)

• Jo J, Lee SY, Kwon W, Lee SJ, Lee JY, Lee SH, Shin D, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Choi KH, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Lee SY, Lee JM; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided Versus Angiography-Guided Complex PCI in Patients With High Bleeding Risk: A Secondary Analysis of the RENOVATE-COMPLEX PCI Trial. Circ Cardiovasc Interv. 2025 Mar;18(3):e014952. doi: 10.1161/CIRCINTERVENTIONS.124.014952. Epub 2025 Mar 18.

  PMID: 40100948 DERIVED

• Lee JM, Lee SY, Kwon W, Lee SJ, Lee JY, Lee SH, Shin D, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Choi KH, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging Predictors Associated With Cardiovascular Events After Complex PCIs. Circ Cardiovasc Interv. 2025 Feb;18(2):e014920. doi: 10.1161/CIRCINTERVENTIONS.124.014920. Epub 2025 Feb 18.

  PMID: 39965046 DERIVED

• Lee SY, Lee SJ, Kwon W, Lee SH, Shin D, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Choi KH, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Lee JY, Lee JM, Investigators TR. Outcomes of intravascular imaging-guided percutaneous coronary intervention according to lesion complexity. EuroIntervention. 2025 Feb 3;21(3):e171-e182. doi: 10.4244/EIJ-D-24-00755.

  PMID: 39901632 DERIVED

• Hong D, Ha J, Choi KH, Lee SH, Shin D, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Park TK, Lee JM; RENOVATE-COMPLEX-PCI Investigators. Prognostic impact of intravascular imaging in percutaneous coronary intervention according to atherothrombotic risk: a post hoc analysis of a randomized clinical trial. Rev Esp Cardiol (Engl Ed). 2025 Jun;78(6):542-552. doi: 10.1016/j.rec.2024.11.007. Epub 2024 Dec 4. English, Spanish.

  PMID: 39643207 DERIVED

• Choi KH, Park TK, Song YB, Lee JM, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Yang JH, Choi SH, Gwon HC, Hahn JY, Nam CW; RENOVATE COMPLEX-PCI Investigators. Intravascular Imaging and Angiography Guidance in Complex Percutaneous Coronary Intervention Among Patients With Diabetes: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417613. doi: 10.1001/jamanetworkopen.2024.17613.

  PMID: 38913377 DERIVED

• Lee SY, Choi KH, Kim CJ, Lee JM, Song YB, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Kim SE, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY; RENOVATE-COMPLEX-PCI Investigators. Impact of Intravascular Imaging-Guided Stent Optimization According to Clinical Presentation in Patients Undergoing Complex PCI. JACC Cardiovasc Interv. 2024 May 27;17(10):1231-1243. doi: 10.1016/j.jcin.2024.03.021.

  PMID: 38811104 DERIVED

• Cha JH, Lee JM, Choi KH, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY, Lee WS, Song YB; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided Optimization of Complex Percutaneous Coronary Intervention by Sex: A Subgroup Analysis of the RENOVATE-COMPLEX-PCI Trial. JAMA Cardiol. 2024 May 1;9(5):466-474. doi: 10.1001/jamacardio.2024.0291.

  PMID: 38568686 DERIVED

• Hong D, Lee J, Lee H, Cho J, Guallar E, Choi KH, Lee SH, Shin D, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Kang D, Lee JM; RENOVATE-COMPLEX-PCI Investigators. Cost-Effectiveness of Intravascular Imaging-Guided Complex PCI: Prespecified Analysis of RENOVATE-COMPLEX-PCI Trial. Circ Cardiovasc Qual Outcomes. 2024 Mar;17(3):e010230. doi: 10.1161/CIRCOUTCOMES.123.010230. Epub 2024 Mar 13.

  PMID: 38477162 DERIVED

• Kwon W, Hong D, Choi KH, Lee SH, Shin D, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Park TK, Yang JH, Choi SH, Gwon HC, Song YB, Hahn JY, Lee JM; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided Percutaneous Coronary Intervention Before and After Standardized Optimization Protocols. JACC Cardiovasc Interv. 2024 Jan 22;17(2):292-303. doi: 10.1016/j.jcin.2023.10.062.

  PMID: 38267144 DERIVED

• Kwon W, Choi KH, Song YB, Park YH, Lee JM, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY; RENOVATE COMPLEX-PCI Investigators. Intravascular Imaging in Patients With Complex Coronary Lesions and Chronic Kidney Disease. JAMA Netw Open. 2023 Nov 1;6(11):e2345554. doi: 10.1001/jamanetworkopen.2023.45554.

  PMID: 38019512 DERIVED

• Kwon W, Lee JM, Yun KH, Choi KH, Lee SJ, Lee JY, Lee SY, Kim SM, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY, Song YB; RENOVATE COMPLEX-PCI Investigators. Clinical Benefit of Intravascular Imaging Compared With Conventional Angiography in Left Main Coronary Artery Intervention. Circ Cardiovasc Interv. 2023 Dec;16(12):e013359. doi: 10.1161/CIRCINTERVENTIONS.123.013359. Epub 2023 Nov 29.

  PMID: 38018841 DERIVED

• Lee JM, Choi KH, Song YB, Lee JY, Lee SJ, Lee SY, Kim SM, Yun KH, Cho JY, Kim CJ, Ahn HS, Nam CW, Yoon HJ, Park YH, Lee WS, Jeong JO, Song PS, Doh JH, Jo SH, Yoon CH, Kang MG, Koh JS, Lee KY, Lim YH, Cho YH, Cho JM, Jang WJ, Chun KJ, Hong D, Park TK, Yang JH, Choi SH, Gwon HC, Hahn JY; RENOVATE-COMPLEX-PCI Investigators. Intravascular Imaging-Guided or Angiography-Guided Complex PCI. N Engl J Med. 2023 May 4;388(18):1668-1679. doi: 10.1056/NEJMoa2216607. Epub 2023 Mar 5.

  PMID: 36876735 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Interventions

Percutaneous Coronary Intervention; Drug-Eluting Stents; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Stents; Prostheses and Implants; Equipment and Supplies; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All end points will be independently adjudicated by Clinical Event Adjudication Committee (CEAC).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, open label, two-arm, randomized controlled trial

Study Record Dates

• First Submitted: December 16, 2017
• First Posted: December 22, 2017
• Study Start: May 10, 2018
• Primary Completion: May 10, 2022
• Study Completion: December 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)