Isovue in Peripheral Digital Subtraction Angiography (DSA)

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

No significant differences is expected in observed motion artifacts, heat or pain reported during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bracco Diagnostics, Inc

Criteria

Inclusion Criteria:

• provides written informed consent;

• at least 18 years of age;

• scheduled to undergo peripheral DSA for the diagnosis and/or treatment of PAOD

Exclusion Criteria:

• pregnant or lactating female;

• known allergies to one more more ingredients in wither product;

• history of severe congestive heart failure (Class IV);

• previously enrolled or received an investigational compound within 30 days;

• history of hypersensitivity to iodinated contrast agents;

• renal impairment eGFR <60 mL/min/1.73m2, calculated using the MDRD study equation

• any other medical condition decreasing chances of obtaining reliable data