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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Pulmonary Disease; Carotid Disease; Aortic Disorders
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • The Second Hospital of Anhui Medical University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital of China Medical University
  • Shanxi
    • Shanxi Province, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Xinjiang
    • Wulumuqi, Xinjiang, China, 830054
      • The First Teaching Hospital of Xinjiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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	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.; Other Names: iomeprol injection; Imeron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.; = 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.	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.).; = 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).	2 hours

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Bracco Diagnostics, Inc
• Collaborators: Clinipace Worldwide; Bracco International B.V.
• Investigators: Study Director: Martin Krix, MD, MSc, Bracco Imaging Deutschland

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (ACTUAL): April 30, 2017
• Study Completion (ACTUAL): April 30, 2017

Study Registration Dates

• First Submitted: October 8, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (ESTIMATE): November 4, 2015

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2017
• Last Update Submitted That Met QC Criteria: May 31, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: IOM-122