Back to resultsPilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA
Primary Purpose
Peripheral Arterial Occlusive Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
VISIPAQUE 270
Isovue 250
Sponsored by
About this trial
This is an interventional diagnostic trial for Peripheral Arterial Occlusive Disease
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Isovue 250
VISIPAQUE 270
Arm Description
Outcomes
Primary Outcome Measures
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.
Visual Analog Scale: Patients were asked to mark on a 10 centimeter line where their pain was in the lower extremity of interest, in relation to the 2 extremes: no pain (0) on the far left and worst pain (10) on the far right. Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10. Patients were assessed immediately prior to injection and again immediately following injection.
Secondary Outcome Measures
The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable.
The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00740207
Brief Title
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
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bracco Diagnostics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isovue 250
Arm Type
Active Comparator
Arm Title
VISIPAQUE 270
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
VISIPAQUE 270
Other Intervention Name(s)
Iodixanol Injection
Intervention Description
VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
Intervention Type
Drug
Intervention Name(s)
Isovue 250
Other Intervention Name(s)
Iopamidol Injection
Intervention Description
ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
Primary Outcome Measure Information:
Title
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.
Description
Visual Analog Scale: Patients were asked to mark on a 10 centimeter line where their pain was in the lower extremity of interest, in relation to the 2 extremes: no pain (0) on the far left and worst pain (10) on the far right. Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10. Patients were assessed immediately prior to injection and again immediately following injection.
Time Frame
Immediately prior to power injection run and again immediately following power injection run
Secondary Outcome Measure Information:
Title
The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
Description
Using the following 5-point scale, the Investigator reviewed the images for motion artifact in vessels distal to the knee: 0 = None; 1 = Mild, not significant; 2 = Significant, but correctable; 3 = Degrades image quality; 4 = Images uninterpretable.
Time Frame
Immediately postdose
Title
The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
Description
The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.
Time Frame
Immediately postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven N. Sireci, MD
Organizational Affiliation
Bracco Diagnostics, Inc
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA
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