A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease

GEHC has decided not to provide this detail

Inclusion Criteria:

- Is ≥18 years of age at the time that written informed consent is obtained.

- Is male or is a nonpregnant, nonlactating female who is either surgically sterile or
is postmenopausal. Women of childbearing potential must use adequate contraception
from Screening until 30 days after the Baseline Visit and must have a negative
pregnancy test at the Baseline Visit.

-Is an outpatient who has undergone successful EVAR and is scheduled for his/her next post-
procedural imaging follow-up examination.

- Has previously completed one or more of his or her post-EVAR surveillance imaging
examination(s) that provided evidence on stable post-EVAR status.

- Has a documented diagnosis of stage III or IV CKD and stable renal function.

- Is able to provide written informed consent.

- Is able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

- Is pregnant, lactating, is possibly pregnant, or is actively trying to conceive during
the study period.

- Is a patient for whom an endoleak or other clinically meaningful EVAR-related
complication (as judged by the investigator) has already been discovered.

- Is undergoing surveillance following a Thoracic Endovascular Repair (TEVAR).

- Has a known or suspected history of immediate or delayed hypersensitivity to iodine or
any iodinated contrast medium.

- Is using metformin (e.g., Glucophage®) that cannot be discontinued for the period of
24 hours prior to the Baseline Visit and for at least 48 hours after the imaging
procedure.

- Has been exposed to any intravascular iodinated contrast medium in the 7 days prior to
the Baseline Visit.

- Has congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic
failure/liver cirrhosis.

- Has Stage V CKD.

- Has a pre-existing requirement for renal dialysis.

- Has undergone percutaneous transluminal renal angioplasty (PTRA) within 12 months
before the index EVAR procedure or is scheduled to undergo PTRA during the study
period.

- Has any clinically active, serious, life-threatening disease, medical, or significant
psychiatric condition; has a life expectancy of less than 6 months; or is, in the
Investigator's opinion, unsuitable for participation in the study for any reason.

- Has been enrolled in another clinical study within the 30 days prior to the Screening
Visit or is planned to enroll in another clinical study within the duration of this
study.

- Has been previously enrolled in this study.

- Is using i.v. vasopressor or inotropic medications.

- Has used nonsteroidal anti-inflammatory drugs (NSAIDs) or any nephrotoxic medication
within 48 hours of the Baseline Visit or will do so within 72 hours after the CT
procedure-with the exception of acetylsalicylic acid (Aspirin) at a dose of ≤100 mg
daily (QD).

- Has been hospitalized within 30 days prior to Screening Visit for any reason other
than practical purposes for management of tests or diagnostic assessments.