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

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ClinicalTrials.gov Identifier: NCT03381872
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Joo-Yong Hahn, 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Atherosclerosis Procedure: Percutaneous coronary intervention for complex lesion Device: Drug-eluting stent Device: Intravascular imaging (IVUS or OCT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1620 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, open label, two-arm, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Intravascular Imaging Guidance Versus Angiography-Guidance on Clinical Outcomes After Complex Percutaneous Coronary Intervention (RENOVATE-COMPLEX-PCI)
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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

  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)

Device: Drug-eluting stent
All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.

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 lumen diameter at the distal reference, rounded up to the nearest 0.25mm [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 external elastic membrane diameter at the distal reference, rounded down to the nearest 0.25mm.


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

  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)

Device: Drug-eluting stent
All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.




Primary Outcome Measures :
  1. Target vessel Failure [ Time Frame: 1-year after last patient enrollment ]
    A composite of cardiac death, target vessel MI, and target vessel revascularization


Secondary Outcome Measures :
  1. All-cause death [ Time Frame: 1-year after last patient enrollment ]
  2. Cardiac death [ Time Frame: 1-year after last patient enrollment ]
  3. Target vessel MI without periprocedural MI [ Time Frame: 1-year after last patient enrollment ]
  4. Target vessel MI with periprocedural MI [ Time Frame: 1-year after last patient enrollment ]
  5. Any MI without periprocedural MI [ Time Frame: 1-year after last patient enrollment ]
  6. Any MI with periprocedural MI [ Time Frame: 1-year after last patient enrollment ]
  7. Target lesion revascularization [ Time Frame: 1-year after last patient enrollment ]
    TLR

  8. Target vessel revascularization [ Time Frame: 1-year after last patient enrollment ]
    TVR

  9. Any revascularization [ Time Frame: 1-year after last patient enrollment ]
    ischemia-driven or all

  10. Stent thrombosis [ Time Frame: 1-year after last patient enrollment ]
    definite/probable/possible

  11. Total procedure time [ Time Frame: Immediate after index procedure ]
  12. Total amount of contrast use [ Time Frame: Immediate after index procedure ]
  13. Incidence of contrast-induced nephropathy [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject age 19-85 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 os, body, distal LM bifurcation including non-true bifurcation)
    4. Implanted stent length ≥38mm
    5. Multi-vessel PCI (≥2 vessels 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)

Exclusion Criteria:

  • Target lesions not amenable for PCI by operators' decision
  • Cardiogenic shock (Killip class IV) at presentation
  • Intolerance to Aspirin, Clopidogrel, Plasugrel, Ticagrelor, Heparin, Everolimus, Zotarolimus, Biolimus, or Sirolimus
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381872


Contacts
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Contact: Joo-Yong Hahn, MD, PhD 82-2-3410-6653 ichjy1@gmail.com
Contact: Joo Myung Lee, MD, MPH, PhD 82-2-3410-1246 drone80@hanmail.net

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Joo-Yong Hahn, MD, PhD    82-2-3410-6653    ichjy1@gmail.com   
Contact: Joo Myung Lee, MD, MPH    82-2-3410-1246    drone80@hanmail.net   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Study Chair: Joo-Yong Hahn, MD, PhD Samsung Medical Center
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Responsible Party: Joo-Yong Hahn, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03381872    
Other Study ID Numbers: Renovate16453143
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joo-Yong Hahn, Samsung Medical Center:
Intravascular Imaging
Intravascular Ultrasound
Optical Coherence Tomography
Complex Lesion
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases