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

Not Applicable

Completed

• Conditions: Atherosclerosis; Coronary Artery Disease
• Interventions: Procedure: Percutaneous coronary intervention for complex lesion; Device: Drug-eluting stent; Device: Drug-coated balloon; Device: Intravascular imaging (IVUS or OCT)

• Registration Number: NCT03381872
• Lead Sponsor: Samsung Medical Center

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-12-16
• Study First Submitted QC: 2017-12-20
• Study First Posted: 2017-12-22
• Study Start: 2018-05-10
• Primary Completion: 2022-05-10
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1639

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravascular imaging arm	Percutaneous coronary intervention for complex lesion	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.
Angiography arm	Drug-coated balloon	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.
Intravascular imaging arm	Intravascular imaging (IVUS or OCT)	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.
Angiography arm	Drug-eluting stent	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.
Intravascular imaging arm	Drug-eluting stent	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.
Angiography arm	Percutaneous coronary intervention for complex lesion	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.
Intravascular imaging arm	Drug-coated balloon	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.

Primary Outcome Measures

Name	Time	Method
Target vessel Failure	1-year after last patient enrollment	A composite of cardiac death, target vessel MI, and clinically-driven target vessel revascularization

Secondary Outcome Measures

Name	Time	Method
Cardiac death	1-year after last patient enrollment	cardiac death
Target vessel MI with procedure-related MI	1-year after last patient enrollment	Target vessel MI with procedure-related MI
Target vessel MI without procedure-related MI	1-year after last patient enrollment	Target vessel MI without procedure-related MI
Any MI without procedure-related MI	1-year after last patient enrollment	Any MI without procedure-related MI
Stent thrombosis	1-year after last patient enrollment	definite stent thrombosis
Total amount of contrast use	Immediate after index procedure	Total amount of contrast use during index hospitalization
Total medical cost	1-year after last patient enrollment	Total medical cost
Any MI with procedure-related MI	1-year after last patient enrollment	Any MI with procedure-related MI
Non-target vessel related MI	1-year after last patient enrollment	Non-target vessel related MI
Target vessel failure without procedure-related MI	1-year after last patient enrollment	A composite of cardiac death, spontaneous target vessel MI, and clinically-driven target vessel revascularization
Cardiac death or target-vessel related MI	1-year after last patient enrollment	Cardiac death or target-vessel related MI
All-cause death	1-year after last patient enrollment	any death
Incidence of contrast-induced nephropathy	48-72 hours after index procedure	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
Total procedure time	Immediate after index procedure	Total procedure time during index hospitalization
Target lesion revascularization	1-year after last patient enrollment	TLR
Target vessel revascularization	1-year after last patient enrollment	TVR
Any revascularization	1-year after last patient enrollment	clinically-driven revascularization

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of