Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT — SCALPO  

Coronary Artery Calcification Clinical Trial

Official title: Shockwave Induced Attenuation of Calcified Plaques Quantified With OCT

Status Recruiting

Clinical Trial Summary

The goal of this observational, prospective, multicenter study is to explore local action of coronary calcium fragmentation exerted by endovascular lithotripsy by images acquired with OCT, in patients with coronary artery calcifications responsible for significant stenosis, candidate to PCI. The main question it aims to answer, is the ability of Shockwave System to reduce calcium density in the Region of Interest (ROI) of the vessel wall.

Clinical Trial Description

Coronary arteries with calcific lesions will undergo intravasculary lithotripsy (IVL) treatment; OCT acquisition will be performed before IVL treatment, after IVL treatment and after stent-implantation. All OCT frames will be uploaded on the image processing and analysis program ImageJ (US National Institutes of Health). ROI will be selected as part of image where calcium is located. Image analysis will be performed using frequency histogram of pixel density in the ROI pre- and post-IVL, as a measure of calcium density. Mean pixel density of the ROI before IVL will be compared with mean pixel density of the ROI after IVL, measuring delta pixel density. ;

Related Conditions & MeSH terms

• Calcinosis
• Coronary Artery Calcification

• NCT number: NCT05973994
• Study type: Observational [Patient Registry]
• Source: University of Rome Tor Vergata
• Contact: Giuseppe M Sangiorgi, Professor
• Phone: 0620904009
• Email: gsangiorgi@gmail.com
• Status: Recruiting
• Start date: February 21, 2022
• Completion date: June 30, 2024