Saline Vs Contrast Optical Coherence Tomography: A Prospective Multicenter Trial

This will be a Prospective, Multicentre Observational study at various centers across India.  The present study is being conducted at multiple centres to do a head to head comparison of images and dimensions obtained during Contrast and Saline FD-OCT during per-cutaneous coronary intervention (PCI).

Pairs of OCT runs will be analysed at core lab an expert investigator who is blinded to the identify of the of the runs. Three anatomically identical frames will be compared for measurements between saline and contrast run. Pre PCI pair of runs will be analysed and compared for luminal area (MLA), proximal reference diameter (PRD), distal reference diameter (DRD) and post PCI runs will be analysed for minimum stent area (MSA) and PRD/DRD at stent edges. To ensure that the quantitative analysis is done at the same anatomical point in both the heparinised saline and contrast runs, anatomical landmarks like side branch, macrophages, calcium thickness, cholesterol crystal and dissections will be identified during OCT analysis. PRD and DRD will be measured using the external elastic lamina wherever possible, otherwise luminal dimensions will be noted. Multiple markers will be used to confirm that the vessel dimensions were measured at the same anatomical position in both the runs regardless of the distance from the MLA as vessel length may vary considerably during the cardiac cycle.