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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014