Clinical trial NCT00740207: Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA
Official title: A Phase IV Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Occlusive Disease
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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.

Primary outcomes:
measure: Level of Pain in the Lower Extremities Scored by the Participants on the Visual Analog Scale Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
timeFrame: Immediately prior to power injection run and again immediately following power injection run
Secondary outcomes:
measure: The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
timeFrame: Immediately postdose
measure: The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
timeFrame: Immediately postdose
Other outcomes:
Locations:
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Steven N. Sireci, MD
role: STUDY_CHAIR
References: