Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bracco International B.V. | UNKNOWN |
| Clinipace Worldwide | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iomeron | Other | Patients will undergo a injection of Iomeron if they are scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or peripheral MDCTA examination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iomeron | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with an 3 point scoring system used for assessing diagnostic image quality | 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.
| 2 hours |
| Number of participants with an 3 point scoring system used for visual assessment of contrast enhancement and delineation of vascular structures/abnormalities | 0 = Insufficient: Generally poor enhancement and delineation of major vascular structures/abnormalities (e.g. major endoleaks, aneurysms, bleeding, etc.).
| 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 2 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Is a pregnant or lactating female. Exclude the possibility of pregnancy:
by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of investigational product administration, by surgical history (e.g., tubal ligation or hysterectomy),post-menopausal with a minimum 1 year without menses;
Has any known allergy to one or more of the ingredients of IOMERON or a history of hypersensitivity to iodinated contrast agents;
Has moderate to severe renal impairment;
Has received an investigational compound and/or medical device within 30 days before admission into this study;
Has been enrolled previously to this study
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Krix, MD, MSc | Bracco Imaging Deutschland | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China | ||
| Wuhan Union Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15015879 | Background | Fleischmann D. High-concentration contrast media in MDCT angiography: principles and rationale. Eur Radiol. 2003 Nov;13 Suppl 3:N39-43. doi: 10.1007/s00330-003-0005-1. No abstract available. | |
| 20574084 | Background | Bae KT. Intravenous contrast medium administration and scan timing at CT: considerations and approaches. Radiology. 2010 Jul;256(1):32-61. doi: 10.1148/radiol.10090908. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001018 | Aortic Diseases |
| D008171 | Lung Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012140 | Respiratory Tract Diseases |
| D050197 | Atherosclerosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C057937 | iomeprol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Wuhan |
| Hubei |
| 430022 |
| China |
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110004 | China |
| The First Affiliated Hospital of Xi'an Jiaotong University | Shanxi Province | Shanxi | 710061 | China |
| The First Teaching Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 830054 | China |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |