NCT01255722

Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography

Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography (X-ACT Study)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 468 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).

Detailed description

Patients suspected of coronary artery disease were submitted to coronary CT angiography using either iobitridol or contrast agents with higher iodine concentrations (iopromide or iomeprol). Independent off-site readers evaluated image quality regarding the ability to identify coronary artery stenosis (score 0- non evaluable to 4- excellent quality). The study was aimed at showing the non-inferiority of iobitridol in its ability to provide evaluable CT scans for the identification of coronary stenosis.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	iobitridol	single IV injection
DRUG	iopromide	Single IV injection
DRUG	iomeprol	Single IV injection

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-12-07
• Last updated: 2015-12-16
• Results posted: 2015-12-16

Locations

23 sites across 5 countries: France, Germany, Italy, Spain, Switzerland