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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Bracco Diagnostics, Inc

Criteria

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.