Peripheral Arterial Occlusive Disease
Conditions
Keywords
Peripheral arterial occlusive disease (PAOD)
Brief 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.
Interventions
DRUGiopamidol
Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral 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).
DRUGiodixanol
Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral 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).
Sponsors
Bracco Diagnostics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | immediately after administration of agent using a power injector for the administration | The 10-centimeter Pain VAS was completed by the Group 1 patients to assess his/her pain level (not scoring heat separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain. The 10-centimeter Pain VAS (excluding Heat assessment, which was separately assessed) was completed by the Group 2 patients to assess his/her pain level in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain. Group 1 completed the Pain VAS (heat not separate from pain). Group 2 completed the Pain VAS for pain only and, separately, the Heat VAS for heat only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Immediately after administration of agent using a power injector for the administration | The 10-centimeter Heat VAS was completed by the Group 2 patients to assess his/her heat level (separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no heat and the right end (10 cm) of the scale indicating the worst heat. The Heat VAS was completed by the patient before completing the Pain VAS to assess pain. |
| 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. | 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. Scores of 3 and 4 were counted as significant motion artifacts. |
| 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. |
| The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA | Immediately postdose | The Investigator assessed all study images obtained for each patient using a 2-point scale (1 = adequate quality; 2 = inadequate quality); assessment was independent of factors or problems relating to the underlying patient condition or the imaging parameters selected. Results are provided for patients with adequate quality. |
Countries
United States
Participant flow
Recruitment details
Study start date: April 2010 (first patient received study agent); Study completion date: December 2011 (final collection date for primary outcome measure) This study was conducted in 6 clinical sites across the United States and 1 in Canada.
Participants by arm
| Arm | Count |
|---|---|
| Isovue 250 Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral 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). | 84 |
| Visipaque 270 Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral 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). | 85 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Visipaque 270 | Total | Isovue 250 |
|---|---|---|---|
| Age Continuous | 63.1 years STANDARD_DEVIATION 8.65 | 63.6 years STANDARD_DEVIATION 8.7 | 64.1 years STANDARD_DEVIATION 8.77 |
| Race/Ethnicity, Customized Asian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Black or African American | 13 participants | 28 participants | 15 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 71 participants | 139 participants | 68 participants |
| Sex: Female, Male Female | 28 Participants | 58 Participants | 30 Participants |
| Sex: Female, Male Male | 57 Participants | 111 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 84 | 1 / 85 |
| serious Total, serious adverse events | 1 / 84 | 1 / 85 |
Outcome results
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
The 10-centimeter Pain VAS was completed by the Group 1 patients to assess his/her pain level (not scoring heat separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain. The 10-centimeter Pain VAS (excluding Heat assessment, which was separately assessed) was completed by the Group 2 patients to assess his/her pain level in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no pain and the right end (10 cm) of the scale indicating the worst pain. Group 1 completed the Pain VAS (heat not separate from pain). Group 2 completed the Pain VAS for pain only and, separately, the Heat VAS for heat only.
Time frame: immediately after administration of agent using a power injector for the administration
Population: Patients who received study agent, had the corresponding endpoint evaluations available and had no deviations from the planned protocol were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Isovue 250 VAS Score Prior to Injection (Baseline) | 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 | Group 2 pain and heat separate (n=35,35,34,34) | 0.4 centimeters | Standard Deviation 1.5 |
| Isovue 250 VAS Score Prior to Injection (Baseline) | 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 | Group 1 pain and heat not separate (n=42,42,48,48) | 0.6 centimeters | Standard Deviation 1.64 |
| Isovue 250 VAS Score Immediately After Injection | 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 | Group 1 pain and heat not separate (n=42,42,48,48) | 3.1 centimeters | Standard Deviation 3.2 |
| Isovue 250 VAS Score Immediately After Injection | 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 | Group 2 pain and heat separate (n=35,35,34,34) | 1.2 centimeters | Standard Deviation 2.1 |
| Visipaque 270 VAS Score Prior to Injection (Baseline) | 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 | Group 1 pain and heat not separate (n=42,42,48,48) | 0.3 centimeters | Standard Deviation 0.87 |
| Visipaque 270 VAS Score Prior to Injection (Baseline) | 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 | Group 2 pain and heat separate (n=35,35,34,34) | 0.2 centimeters | Standard Deviation 0.77 |
| Visipaque 270 VAS Score Immediately After Injection | 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 | Group 2 pain and heat separate (n=35,35,34,34) | 0.8 centimeters | Standard Deviation 1.76 |
| Visipaque 270 VAS Score Immediately After Injection | 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 | Group 1 pain and heat not separate (n=42,42,48,48) | 0.7 centimeters | Standard Deviation 1.52 |
p-value: <0.000195% CI: [1.4, 3.5]t-test, 2 sided
p-value: 0.324495% CI: [-0.5, 1.4]t-test, 2 sided
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
The 10-centimeter Heat VAS was completed by the Group 2 patients to assess his/her heat level (separately from pain) in the lower extremity of interest. The scale was 0 to 10 cm, with the left end (0 cm)of the scale indicating no heat and the right end (10 cm) of the scale indicating the worst heat. The Heat VAS was completed by the patient before completing the Pain VAS to assess pain.
Time frame: Immediately after administration of agent using a power injector for the administration
Population: Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Group 2 patients provided an assessment of heat by the Heat VAS prior to assessing pain by the Pain VAS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Isovue 250 VAS Score Prior to Injection (Baseline) | 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 centimeters | Standard Deviation 2.57 |
| Isovue 250 VAS Score Immediately After Injection | 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 | 1.7 centimeters | Standard Deviation 2.1 |
p-value: 0.005995% CI: [0.5, 2.7]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
Population: Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 250 VAS Score Prior to Injection (Baseline) | The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | 3 participants |
| Isovue 250 VAS Score Immediately After Injection | The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. | 1 participants |
Secondary
The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
The Investigator assessed all study images obtained for each patient using a 2-point scale (1 = adequate quality; 2 = inadequate quality); assessment was independent of factors or problems relating to the underlying patient condition or the imaging parameters selected. Results are provided for patients with adequate quality.
Time frame: Immediately postdose
Population: Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 250 VAS Score Prior to Injection (Baseline) | The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA | 75 participants |
| Isovue 250 VAS Score Immediately After Injection | The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA | 82 participants |
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.
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. Scores of 3 and 4 were counted as significant motion artifacts.
Time frame: Immediately postdose
Population: Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis. Patients with significant motion artifact were those with a score of 3 or 4 for motion artifacts in vessels distal to the knee
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Isovue 250 VAS Score Prior to Injection (Baseline) | 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 participants |
| Isovue 250 VAS Score Immediately After Injection | 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 participants |