Status:
COMPLETED
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography
Lead Sponsor:
Guerbet
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
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). Independen...
Eligibility Criteria
Inclusion
- Male or female adult patient (having reached legal majority age)
- Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT01255722
Start Date
November 1 2010
End Date
September 1 2012
Last Update
December 16 2015
Active Locations (23)
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1
CHU Angers
Angers, France, 49033
2
CHU de la Cavale Blanche
Brest, France, 29609
3
Centre Chirurgical Marie Lannelongue
Le Plessis-Robinson, France, 92350
4
La Timone Adultes
Marseille, France, 13385