A Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA) (Iomeron®-400)
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|ClinicalTrials.gov Identifier: NCT02596048|
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Aortic Disorders Carotid Disease Pulmonary Disease Peripheral Artery Disease||Other: Iomeron||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||224 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||April 30, 2017|
|Actual Study Completion Date :||April 30, 2017|
Patients will undergo a injection of Iomeron if they are scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or peripheral MDCTA examination
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.
- Number of participants with an 3 point scoring system used for assessing diagnostic image quality [ Time Frame: 2 hours ]
0 = Insufficient: Impaired image quality precludes adequate diagnostic assessment of vascular abnormalities (stenosis, embolism, dissection, etc.) because of severe noise, or severe artifacts, or insufficient contrast enhancement.
- = Adequate: Image quality is sufficient for adequate diagnostic assessment of vascular abnormalities (stenosis, embolism, dissection etc.), even in presence of minimal noise, or minimal artifacts and sufficient contrast enhancement.
- = Good: Image quality allows adequate, complete and rapid diagnostic assessment of vascular abnormalities (stenosis, embolism, dissection etc.) with absent or very minimal noise, or absent or very minimal artifacts, and optimal contrast enhancement.
- Number of participants with an 3 point scoring system used for visual assessment of contrast enhancement and delineation of vascular structures/abnormalities [ Time Frame: 2 hours ]
0 = Insufficient: Generally poor enhancement and delineation of major vascular structures/abnormalities (e.g. major endoleaks, aneurysms, bleeding, etc.).
- = Adequate: Sufficient enhancement and delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc).
- = Good: Optimal enhancement and complete delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc).
- Comparing number of participants undergoing x-ray angiography as the truth standard with the diagnostic performance of MDCTA diagnosis using a two point scoring system [ Time Frame: 2 hours ]
0 = Inadequate: Relevant aspects of MDCTA diagnosis do not match with the truth standard
1 = Adequate: Relevant aspects of the MDCTA diagnosis match with the truth standard
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596048
|The Second Hospital of Anhui Medical University|
|Hefei, Anhui, China, 230601|
|Wuhan Union Hospital|
|Wuhan, Hubei, China, 430022|
|Shengjing Hospital of China Medical University|
|Shenyang, Liaoning, China, 110004|
|The First Affiliated Hospital of Xi'an Jiaotong University|
|Shanxi Province, Shanxi, China, 710061|
|The First Teaching Hospital of Xinjiang Medical University|
|Wulumuqi, Xinjiang, China, 830054|
|Study Director:||Martin Krix, MD, MSc||Bracco Imaging Deutschland|