The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale

Evan Shlofmitz, Rebecca Torguson, Gary S. Mintz, Cheng Zhang, Andrew Sharp, John Mc B. Hodgson, Binita Shah, Gautam Kumar, Jasvindar Singh, Becky Inderbitzen, William S. Weintraub, Hector M. Garcia-Garcia, Carlo Di Mario, Ron Waksman

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)65-71
Number of pages7
JournalAmerican heart journal
Volume228
DOIs
StatePublished - Oct 2020

Fingerprint

Dive into the research topics of 'The IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact (IMPROVE) trial: Study design and rationale'. Together they form a unique fingerprint.

Cite this