Status:
COMPLETED
Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA
Lead Sponsor:
Bracco Diagnostics, Inc
Conditions:
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00740207
Start Date
September 1 2008
End Date
July 1 2009
Last Update
May 9 2011
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