This multi-center, prospective, unblinded, stratified, 1:1 randomized controlled trial was designed to assess whether using DCR can reduce the total iodinated contrast volume used during PCI procedures. A secondary objective was to assess the total number of contrast-enhanced cine angiographic X-ray runs (angiograms) related to PCI.
The study population comprised a total of 394 patients requiring PCI, recruited from a total of six centers – three in Europe, one in Israel and two in the United States.
Patients were randomized and stratified within each type of PCI (ad hoc or elective), according to the number of vessels to be treated. Patients within the experimental group underwent PCI procedures where DCR was used to guide the advancement of coronary wires, balloons, stents and other PCI diagnostic or therapeutic devices. Patients assigned to the control group underwent PCI without DCR support.