A Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA)

Phase 4

Completed

• Conditions: Peripheral Artery Disease; Aortic Disorders; Carotid Disease; Pulmonary Disease
• Interventions: Other: Iomeron

• Registration Number: NCT02596048
• Lead Sponsor: Bracco Diagnostics, Inc

Brief 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.

Study Timeline

• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-04
• Study Start: 2015-12
• Primary Completion: 2017-04-30
• Study Completion: 2017-04-30
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. Provides written Informed Consent and is willing to comply with protocol requirements
2. Is at least 18 years of age.
3. Is scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or peripheral MDCTA examination.

Exclusion Criteria

1. 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;

2. Has any known allergy to one or more of the ingredients of IOMERON or a history of hypersensitivity to iodinated contrast agents;

3. Has moderate to severe renal impairment;

4. Has received an investigational compound and/or medical device within 30 days before admission into this study;

5. Has been enrolled previously to this study

6. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iomeron	Iomeron	Patients will undergo a injection of Iomeron if they are scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or peripheral MDCTA examination

Primary Outcome Measures

Name	Time	Method
Number of participants with an 3 point scoring system used for assessing diagnostic image quality	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.; 1. = 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.; 2. = 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	2 hours	0 = Insufficient: Generally poor enhancement and delineation of major vascular structures/abnormalities (e.g. major endoleaks, aneurysms, bleeding, etc.).; 1. = Adequate: Sufficient enhancement and delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc).; 2. = Good: Optimal enhancement and complete delineation of vascular structures/abnormalities (e.g. small bleeding, endoleaks, etc).

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (5)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

The First Teaching Hospital of Xinjiang Medical University; 🇨🇳 Wulumuqi, Xinjiang, China

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Shanxi Province, Shanxi, China