Phase 4
N=169
Isovue in Peripheral Digital Subtraction Angiography (DSA)
Peripheral Arterial Occlusive Disease
Bottom Line
View on ClinicalTrials.gov: NCT01075217 ↗Enrolled (actual)
169
Serious AEs
1.2%
Results posted
May 2013
Primary outcome: Primary: Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA — 0.6; 3.1; 0.3; 0.7 centimeters — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- iopamidol (Drug); iodixanol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bracco Diagnostics, Inc
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Pain/Heat in the Lower Extremities Scored by the Participants on the Visual Analog Scale (VAS) Following Intra-arterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA |
0.6; 3.1; 0.3; 0.7; 0.4; 1.2 | <0.0001 sig |
| SECONDARY Level of Heat in the Lower Extremities Scored by Group 2 as Assessed on the Heat VAS Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA |
3.3; 1.7 | 0.0059 sig |
| SECONDARY The Number of Participants With Significant Motion Artifacts (Scores of 3 or 4) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. |
2; 2 | — |
| SECONDARY The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. |
3; 1 | — |
| SECONDARY The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA |
75; 82 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01075217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.