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| Name | Class |
|---|---|
| i3 Statprobe | INDUSTRY |
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The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Arm | Active Comparator |
| |
| Comparator Arm | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodixanol | Drug | Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography | The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging. | Within 10 minutes post contrast administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. | Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration. | Within 10 minutes post contrast administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Lim, PharmD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
Total of 255 subjects enrolled in this study. 2 subjects discontinued the study prior to contrast administration. Therefore, 253 subjects completed the study.
255 subjects were enrolled in this study. Two (2) subjects did not complete the study. Total number of subjects that completed the study was 253.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iodixanol 320mgI/mL | Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. |
| FG001 | Iopamidol 370mgI/mL | Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iodixanol 320mgI/mL | Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. |
| BG001 | Iopamidol 370mgI/mL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography | The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging. | 249 subjects completed assessments, for overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.124 subjects received Iodixanol and 125 subjects received Iopamidol. | Posted | Number | participants | Within 10 minutes post contrast administration. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iodixanol 320mgI/mL | Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photopsia | Eye disorders | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Debra Mansfield | GE Healthcare | 609-514-6329 | dabra.mansfield@ge.com |
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| ID | Term |
|---|---|
| C044834 | iodixanol |
| D007479 | Iopamidol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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|
| Iopamidol | Drug | Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. |
|
|
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. |
|
|
| Secondary | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. | Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration. | A recruitment error occurred with a subject in each treatment group. Therefore, the subject's efficacy data were excluded from this efficacy analysis. This resulted in a total of 126 Iodixanol subjects and a total 125 Iopamidol subjects were used in the imaging analysis. | Posted | Number | participants | Within 10 minutes post contrast administration. |
|
|
|
| 2 |
| 127 |
| 15 |
| 127 |
| EG001 | Iopamidol 370mgI/mL | Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration. | 2 | 126 | 3 | 126 |
| Ventricular Fibrillation | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vessel Puncture Site Hematoma | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Retroperitoneal Hemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hemorrhage from femoral common artery | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypovolemic Shock | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Poor |
|