TY - JOUR
T1 - The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial
T2 - Study design and rationale
AU - Shlofmitz, Evan
AU - Torguson, Rebecca
AU - Mintz, Gary S.
AU - Zhang, Cheng
AU - Sharp, Andrew
AU - Hodgson, John Mc B.
AU - Shah, Binita
AU - Kumar, Gautam
AU - Singh, Jasvindar
AU - Inderbitzen, Becky
AU - Weintraub, William S.
AU - Garcia-Garcia, Hector M.
AU - Di Mario, Carlo
AU - Waksman, Ron
N1 - Funding Information:
Funding: This study is sponsored by the MedStar Cardiovascular Research Network , Washington, DC, USA. The trial has been supported by grants from Philips (Amsterdam, Netherlands) and Medtronic Vascular (Minneapolis, MN, USA).
Funding Information:
Funding: This study is sponsored by the MedStar Cardiovascular Research Network, Washington, DC, USA. The trial has been supported by grants from Philips (Amsterdam, Netherlands) and Medtronic Vascular (Minneapolis, MN, USA).This is a prospective, clinical trial randomizing subjects to IVUS-guided coronary stent implantation or conventional angiography-guided coronary stent implantation in a 1:1 ratio. Subjects will be blinded to their treatment assignment, and blinding will be maintained until the completion of the trial. The clinical trial will enroll 2,500 to 3,100 randomized subjects using an adaptive trial design at approximately 120 centers in North America and Europe. Subjects participating in this clinical trial will be followed for 2 years. The study flowchart is depicted in Figure 1. The IMPROVE trial is registered at ClinicalTrials.gov and assigned the identifier NCT04221815. The trial is approved by the institutional review board at Advarra (Columbia, MD). This study is sponsored by the MedStar Cardiovascular Research Network, Washington, DC, USA. The trial has been supported by grants from Philips (Amsterdam, Netherlands) and Medtronic Vascular (Minneapolis, MN, USA). The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper, and its final contents.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/10
Y1 - 2020/10
N2 - Intravascular ultrasound (IVUS)–guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The “IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact” trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel–related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.
AB - Intravascular ultrasound (IVUS)–guided percutaneous coronary intervention (PCI) has been shown in clinical trials, registries, and meta-analyses to reduce recurrent major adverse cardiovascular events after PCI. However, IVUS utilization remains low. An increasing number of high-risk or complex coronary artery lesions are treated with PCI, and we hypothesize that the impact of IVUS in guiding treatment of these complex lesions will be of increased importance in reducing major adverse cardiovascular events while remaining cost-effective. The “IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact” trial (registered on clinicaltrials.gov: NCT04221815) is a multicenter, international, clinical trial randomizing subjects to IVUS-guided versus angiography-guided PCI in a 1:1 ratio. Patients undergoing PCI involving a complex lesion are eligible for enrollment. Complex lesion is defined as involving at least 1 of the following characteristics: chronic total occlusion, in-stent restenosis, severe coronary artery calcification, long lesion (≥28 mm), or bifurcation lesion. The clinical investigation will be conducted at approximately 120 centers in North America and Europe, enrolling approximately 2,500 to 3,100 randomized subjects with an adaptive design. The primary clinical end point is the rate of target vessel failure at 12 months, defined as the composite of cardiac death, target vessel–related myocardial infarction, and ischemia-driven target vessel revascularization. The co-primary imaging end point is the final post-PCI minimum stent area assessed by IVUS. The primary objective of this study is to assess the impact of IVUS guidance on the PCI treatment of complex lesions.
UR - http://www.scopus.com/inward/record.url?scp=85089838273&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2020.08.002
DO - 10.1016/j.ahj.2020.08.002
M3 - Article
C2 - 32866927
AN - SCOPUS:85089838273
SN - 0002-8703
VL - 228
SP - 65
EP - 71
JO - American heart journal
JF - American heart journal
ER -