Peripheral Arterial Occlusive Disease
Conditions
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.
Interventions
DRUGVISIPAQUE 270
VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
DRUGIsovue 250
ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Immediately prior to power injection run and again immediately following power injection run | 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
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | Immediately postdose | 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. | Immediately postdose | The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant. |
Participant flow
Recruitment details
The first patient to participate in this study was dosed on September 17, 2008; the last patient on June 15, 2009.
Participants by arm
| Arm | Count |
|---|---|
| ISOVUE 250 Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot). | 17 |
| VISIPAQUE 270 Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot). | 16 |
| Total | 33 |
Baseline characteristics
| Characteristic | ISOVUE 250 | VISIPAQUE 270 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 9 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 7 Participants | 13 Participants |
| Age Continuous | 65.9 years STANDARD_DEVIATION 9.42 | 66.9 years STANDARD_DEVIATION 9.93 | 66.4 years STANDARD_DEVIATION 9.53 |
| Region of Enrollment Canada | 10 participants | 10 participants | 20 participants |
| Region of Enrollment United States | 7 participants | 6 participants | 13 participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 21 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 16 |
Outcome results
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.
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
Population: Patients who did not deviate from the planned protocol.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| VAS Score Prior to Injection of ISOVUE 250 | 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. | (0) None | 8 Participants | 1.35 |
| VAS Score Prior to Injection of ISOVUE 250 | 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. | (1) Mild | 0 Participants | — |
| VAS Score Prior to Injection of ISOVUE 250 | 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. | (2) Moderate | 2 Participants | — |
| VAS Score Prior to Injection of ISOVUE 250 | 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. | (3) Severe | 0 Participants | — |
| VAS Score After Injection of ISOVUE 250 | 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. | (1) Mild | 1 Participants | — |
| VAS Score After Injection of ISOVUE 250 | 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. | (2) Moderate | 3 Participants | — |
| VAS Score After Injection of ISOVUE 250 | 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. | (3) Severe | 0 Participants | — |
| VAS Score After Injection of ISOVUE 250 | 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. | (0) None | 6 Participants | 1.03 |
| VAS Score Prior to Injection of VISIPAQUE 270 | 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. | (2) Moderate | 2 Participants | — |
| VAS Score Prior to Injection of VISIPAQUE 270 | 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. | (1) Mild | 1 Participants | — |
| VAS Score Prior to Injection of VISIPAQUE 270 | 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. | (3) Severe | 0 Participants | — |
| VAS Score Prior to Injection of VISIPAQUE 270 | 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. | (0) None | 7 Participants | — |
| VAS Score After Injection of VISIPAQUE 270 | 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. | (3) Severe | 0 Participants | — |
| VAS Score After Injection of VISIPAQUE 270 | 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. | (1) Mild | 7 Participants | — |
| VAS Score After Injection of VISIPAQUE 270 | 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. | (0) None | 2 Participants | — |
| VAS Score After Injection of VISIPAQUE 270 | 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. | (2) Moderate | 1 Participants | — |
Comparison: Paired t-test to compare difference between the investigational product's mean change from predose to postdosep-value: 0.714295% CI: [-1.3, 0.9]t-test, 2 sided
Secondary
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.
Time frame: Immediately postdose
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VAS Score Prior to Injection of ISOVUE 250 | The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | 0 Participants |
| VAS Score After Injection of ISOVUE 250 | The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | 1 Participants |
Comparison: Paired t-test to compare difference in percentage between the number of participants requiring repeat injectionsp-value: 195% CI: [-28.6, 8.6]Fisher Exact
Secondary
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.
Time frame: Immediately postdose
Population: Patients who did not deviate from the planned protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VAS Score Prior to Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (1) Mild, Not significant | 1 Participants |
| VAS Score Prior to Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (3) Degrades Image Quality | 0 Participants |
| VAS Score Prior to Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (2) Significant, But Correctable | 1 Participants |
| VAS Score Prior to Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (4) Images Uninterpretable | 0 Participants |
| VAS Score Prior to Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (0) No Motion Artifacts | 8 Participants |
| VAS Score After Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (4) Images Uninterpretable | 0 Participants |
| VAS Score After Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (0) No Motion Artifacts | 4 Participants |
| VAS Score After Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (1) Mild, Not significant | 5 Participants |
| VAS Score After Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (2) Significant, But Correctable | 1 Participants |
| VAS Score After Injection of ISOVUE 250 | The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | (3) Degrades Image Quality | 0 Participants |
Comparison: Paired t-test to compare the difference in percentage between the portions of patients who had motion artifacts.p-value: 0.169895% CI: [-79.2, -0.8]Fisher Exact