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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guerbet

Criteria

Inclusion Criteria:

• Male or female adult patient (having reached legal majority age)

• Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography

Exclusion Criteria:

• Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration

• Patient with arrhythmia or non-sinus rhythm

• Patient with decompensated heart failure

• Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema)

• Patient who has previously undergone coronary artery bypass graft

• Patient who has previously undergone percutaneous transluminal coronary stent placement

• Patient with artificial heart valve

• Patient with known moderate to severe aortic stenosis