Philips has initiated the randomised RADIQAL trial to assess its new ultra-low X-ray dose technology in treating coronary artery disease (CAD).

According to the company, CAD is the most frequent type of heart disease worldwide. Percutaneous coronary intervention (PCI) is used to treat it, comprising a minimally invasive treatment by opening the blocked coronary arteries.

Philips noted that its Azurion image-guided therapy system, which utilises live X-ray imaging during PCI, will be central to the RADIQAL trial.

The multicentre trial aims to compare radiation exposure, quality of the image, and procedural performance between the company’s ultra-low dose technology and the current ClarityIQ technology. These technologies are integrated into the Azurion system.

It is set to enrol 824 subjects across six hospitals in the US, the Czech Republic and Spain, with the first subject enrolled at Aarhus University Hospital in Denmark.

Featuring ultra-low dose protocol, the new technology aims to minimise X-ray exposure by 50% against the lowest setting on current Azurion systems with ClarityIQ.

It has secured CE marking, indicating compliance with the European Union Medical Device Regulation (EU-MDR) regulatory framework.

Philips image-guided therapy devices medical and clinical head Dr Darshan Doshi said: “Reducing radiation exposure while maintaining or improving image-quality is one of the most important innovation goals in interventional cardiology.”

The study will involve subject screening, baseline evaluation, randomisation, and treatment with either the Azurion system with Xres5 or control (ClarityIQ) technology.

Subjects will be randomised in the intervention or control group in a 1:1 ratio. The coronary procedure will follow institutional standards, with image processing based on randomisation outcomes.

Operators can switch to the standard of care imaging if necessary. In EU trial sites, primary staff will wear electronic dosimeters to log radiation exposure.

Post-procedure, subject characteristics and procedure data will be recorded in an electronic case report form (eCRF), and imaging runs will be uploaded to the cloud following de-identification.

The study will conclude after the coronary procedure, without altering standard treatment or follow-up of the patient.

Before the RADIQAL trial, the company launched the VeriSight Pro 3D intracardiac echocardiography (ICE) catheter in Europe.

"Philips initiates trial to test X-ray dose technology for CAD" was originally created and published by Medical Device Network, a GlobalData owned brand.