Phase 4
N=33
Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA
Peripheral Arterial Occlusive Disease
Bottom Line
View on ClinicalTrials.gov: NCT00740207 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: 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. — 8; 6; 7; 2 Participants — p=0.7142
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- VISIPAQUE 270 (Drug); Isovue 250 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bracco Diagnostics, Inc
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
8; 6; 7; 2; 0; 1 | 0.7142 |
| SECONDARY The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. |
8; 4; 1; 5; 1; 1 | 0.1698 |
| SECONDARY The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. |
0; 1 | 1.000 |
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.
Data sourced from ClinicalTrials.gov (NCT00740207). 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.