WASHINGTON, DC – The IMPROVE (IMPact on Revascularization Outcomes of intraVascular ultrasound-guided treatment of complex lesions and Economic impact) trial will randomize 3,100 patients at up to 100 centers in North America and Europe who are candidates for percutaneous coronary intervention (PCI) of complex lesions to undergo guidance by intravascular ultrasound (IVUS) or by conventional angiography. Complex lesions will include severe calcification, bifurcations, in-stent restenosis, chronic total occlusions, Type C, and long lesions.
Ron Waksman, MD, Director of Cardiovascular Research and Advanced Education for MedStar Heart & Vascular Institute, Washington, DC, is the Study Chairman. The international Principal Investigator will be Carlo Di Mario, MD, of Careggi University Hospital, Florence, Italy, and core lab oversight will be provided by Hector M. Garcia-Garcia, MD, Ph.D. and Gary S. Mintz, MD, both of MedStar Cardiovascular Research Network, Washington, DC.
“We have been waiting for 30 years, since the introduction of IVUS-assisted PCI, for a definitive study to support the importance of imaging-guided PCI by IVUS,” Waksman said. “We are thrilled that, finally, we can undertake this important study.”
The study is sponsored by the MedStar Cardiovascular Research Network in collaboration with Philips and Medtronic Vascular.
Philips’ IVUS system will be used to guide PCI in patients in the IVUS arm. PCI will be performed with implantation of Medtronic’s Onyx Resolute drug-eluting stent.
“Philips is committed to bringing forward innovations that deliver on the quadruple aim of health care – to improve patient outcomes, staff workflow, patient experience and reduce the overall cost of care,” said Andrew Tochterman, General Manager, Coronary, Image Guided Therapy Devices, Philips. “We are excited about the potential of the IMPROVE clinical trial to assess whether, in a complex PCI patient cohort, use of Intravascular Imaging may generate superior clinical outcomes to angiography alone.”
The primary endpoint will evaluate target vessel failure at 12-month follow-up.
Patient enrollment will begin in 2020.
“IMPROVE is designed to prove once and for all that IVUS-guided stent implantation improves patient outcomes compared to traditional angiographic guidance,” Mintz said.