Trials / Completed
CompletedNCT02596048
A Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA)
A Phase IV Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA) of the Thoraco-Abdominal Aorta, and the Carotid, Pulmonary, and Peripheral Arteries
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 224 (actual)
- Sponsor
- Bracco Diagnostics, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase IV multicenter, open-label study and is being implemented in order to assess diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with IOMERON.
Detailed description
This is a Phase IV multicenter, open-label study and is being implemented in order to assess diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with IOMERON. The hypothesis is that IOMERON used at a high concentration will provide good diagnostic image quality. The Investigators will also function as readers and evaluate the images on-site. Efficacy analysis will be based on the on-site evaluations. Imaging conditions will be representative of those used in routine clinical practice. The study will be conducted at approximately 10-20 sites in China. Each site may enroll approximately 40 subjects in this study. Approximately 400 subjects will be enrolled in order to obtain 360 evaluable subjects who undergo elective MDCTA of the thoraco-abdominal aorta, or carotid, pulmonary or peripheral arteries.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Iomeron | Iomeron or Imeron which is a iomeprol injection, hereafter referred to as iomeprol is an injectable solution of iomeprol, a non-ionic hydrosoluble iodinated compound used as a medical imaging contrast agent for radiological examinations. |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2017-04-30
- Completion
- 2017-04-30
- First posted
- 2015-11-04
- Last updated
- 2017-06-02
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02596048. Inclusion in this directory is not an endorsement.