Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA

• The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. [ Time Frame: Immediately postdose ] [ Designated as safety issue: No ]
  Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable.
• The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. [ Time Frame: Immediately postdose ] [ Designated as safety issue: No ]
  The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.

The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.

• Drug: VISIPAQUE 270
  VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
  Other Name: Iodixanol Injection
• Drug: Isovue 250
  ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
  Other Name: Iopamidol Injection

• Active Comparator: Isovue 250
  Intervention: Drug: Isovue 250
• Active Comparator: VISIPAQUE 270
  Intervention: Drug: VISIPAQUE 270

Inclusion Criteria:

Enroll a patient in this study if the patient meets the following inclusion criteria:

• Provides written Informed Consent and is willing to comply with protocol requirements;
• Is at least 18 years of age;
• Is scheduled to undergo peripheral DSA for the diagnosis and/or treatment (PTA) of PAOD.

Exclusion Criteria:

Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:

• 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 the investigational products;
• Has a history of severe congestive heart failure [class IV in accordance with the classification of the New York Heart Association (NYHA)]
• Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
• Has a history of hypersensitivity to iodinated contrast agents;
• Has renal impairment (eGFR <60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease [MDRD] study equation , );
• 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 postdose follow-up examinations.