Phase 4
N=468
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT01255722 ↗Enrolled (actual)
468
Serious AEs
0.2%
Results posted
Dec 2015
Primary outcome: Primary: Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment — 92.1; 95.4; 94.6 Percentage of patients — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- iobitridol (Drug); iopromide (Drug); iomeprol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Patients With Evaluable CT Scans i.e. Allowing Identification of Coronary Artery Stenosis According to Off-site Reading Assessment |
92.1; 95.4; 94.6 | 0.05 |
| SECONDARY Average Image Quality According to Off-site Reading |
3.5; 3.5; 3.4 | 0.750 |
| SECONDARY Coronary Track Rate |
10.9; 10.8; 11.1 | — |
| SECONDARY Average Signal Attenuation After IV Injection of Contrast |
426.3; 449.8; 466.4 | 0.001 sig |
| SECONDARY Average Signal-to-Noise Ratio (Average SNR) |
16.2; 17.1; 17.6 | 0.109 |
| SECONDARY Average Contrast-to-noise Ratio (Average CNR) |
14.4; 15.3; 15.8 | 0.09 |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01255722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.