On-line three-dimensional OFDI guided PCI vs. angiography guided in bifurcation lesions: design and rationale of the randomized OPTIMUM trial.

On-line three-dimensional OFDI guided PCI vs. angiography guided in bifurcation lesions: design and rationale of the randomized OPTIMUM trial.
EuroIntervention. 2019 Jul 09;:
Authors: Miyazaki Y, Muramatsu T, Asano T, Katagiri Y, Sotomi Y, Nakatani S, Takahashi K, Kogame N, Higuchi Y, Ishikawa M, Kyono H, Yano M, Ozaki Y, Serruys PW, Okamura T, Onuma Y
Abstract
The aim of this trial is to determine the superiority of on-line three-dimensional optical frequency domain imaging (3D-OFDI) guided percutaneous coronary intervention (PCI) to angiography-guided PCI in bifurcation lesions. The OPTIMUM trial is a randomized, active control, superiority, and multi-center clinical trial. The primary endpoint is the post-procedural percentage of malapposed struts assessed by OFDI in the main branch bifurcation region after final kissing-balloon-dilatation. A total 106 patients will be randomly allocated to either 3D-OFDI or angiography guidance PCI. OPTIMUM trial will be the first prospective, randomised trial and evaluate the efficacy and safety of the on-line 3D-OFDI guided PCI.
PMID: 31289018 [PubMed - as supplied by publisher]

Source: EuroIntervention - July 12, 2019 Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research