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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01255722
First received: December 3, 2010
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to demonstrate the statistical non-inferiority of Xenetix® 350 compared to Ultravist® 370 and Iomeron® 400 in terms of coronary CT scan evaluability (quality and interpretability of images).


Condition Intervention Phase
Coronary Artery Disease
 Drug: Xenetix (iobitridol)
Drug: Ultravist (iopromid)
Drug: Iomeron (iomeprol)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic

Resource links provided by NLM:

Drug Information available for: Iopromide
U.S. FDA Resources

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Evaluability of CT scans based upon segments assessment using a 5-point evaluation scale grading the quality and the interpretability of images. [ Time Frame: < 24h ] [ Designated as safety issue: No ]

Enrollment: 468
Study Start Date: November 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xenetix Drug: Xenetix (iobitridol)
single IV injection
Active Comparator: Ultravist Drug: Ultravist (iopromid)
Single IV injection
Active Comparator: Iomeron Drug: Iomeron (iomeprol)
Single IV injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255722

Locations
France
GUERBET
Roissy, France
Sponsors and Collaborators
Guerbet
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01255722     History of Changes
Other Study ID Numbers: ISO-44-012
Study First Received: December 3, 2010
Last Updated: October 1, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Spain: Ministry of Health
Switzerland: Swissmedic

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013