Trial Outcomes & Findings for Isovue in Peripheral Digital Subtraction Angiography (DSA) (NCT NCT01075217)
NCT ID: NCT01075217
Last Updated: 2013-05-30
Results Overview
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.
COMPLETED
PHASE4
174 participants
immediately after administration of agent using a power injector for the administration
2013-05-30
Participant Flow
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.
Participant milestones
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
85
|
|
Overall Study
COMPLETED
|
82
|
84
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
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).
|
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).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Isovue in Peripheral Digital Subtraction Angiography (DSA)
Baseline characteristics by cohort
| Measure |
Isovue 250
n=84 Participants
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).
|
Visipaque 270
n=85 Participants
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).
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.1 years
STANDARD_DEVIATION 8.77 • n=99 Participants
|
63.1 years
STANDARD_DEVIATION 8.65 • n=107 Participants
|
63.6 years
STANDARD_DEVIATION 8.70 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
111 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
68 participants
n=99 Participants
|
71 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
15 participants
n=99 Participants
|
13 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: immediately after administration of agent using a power injector for the administrationPopulation: Patients who received study agent, had the corresponding endpoint evaluations available and had no deviations from the planned protocol were included in the analysis.
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.
Outcome measures
| Measure |
Isovue 250 VAS Score Prior to Injection (Baseline)
n=77 Participants
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).
|
Isovue 250 VAS Score Immediately After Injection
n=77 Participants
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).
|
Visipaque 270 VAS Score Prior to Injection (Baseline)
n=82 Participants
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).
|
Visipaque 270 VAS Score Immediately After Injection
n=82 Participants
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).
|
|---|---|---|---|---|
|
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
|
3.1 centimeters
Standard Deviation 3.20
|
0.3 centimeters
Standard Deviation 0.87
|
0.7 centimeters
Standard Deviation 1.52
|
|
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
|
1.2 centimeters
Standard Deviation 2.10
|
0.2 centimeters
Standard Deviation 0.77
|
0.8 centimeters
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Immediately after administration of agent using a power injector for the administrationPopulation: 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.
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.
Outcome measures
| Measure |
Isovue 250 VAS Score Prior to Injection (Baseline)
n=35 Participants
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).
|
Isovue 250 VAS Score Immediately After Injection
n=34 Participants
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).
|
Visipaque 270 VAS Score Prior to Injection (Baseline)
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).
|
Visipaque 270 VAS Score Immediately After Injection
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).
|
|---|---|---|---|---|
|
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
|
1.7 centimeters
Standard Deviation 2.10
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately postdosePopulation: 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
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.
Outcome measures
| Measure |
Isovue 250 VAS Score Prior to Injection (Baseline)
n=77 Participants
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).
|
Isovue 250 VAS Score Immediately After Injection
n=82 Participants
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).
|
Visipaque 270 VAS Score Prior to Injection (Baseline)
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).
|
Visipaque 270 VAS Score Immediately After Injection
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).
|
|---|---|---|---|---|
|
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
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately postdosePopulation: Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.
The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.
Outcome measures
| Measure |
Isovue 250 VAS Score Prior to Injection (Baseline)
n=77 Participants
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).
|
Isovue 250 VAS Score Immediately After Injection
n=82 Participants
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).
|
Visipaque 270 VAS Score Prior to Injection (Baseline)
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).
|
Visipaque 270 VAS Score Immediately After Injection
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).
|
|---|---|---|---|---|
|
The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
|
3 participants
|
1 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Immediately postdosePopulation: Patients who did not deviate from the planned protocol and had the corresponding endpoint evaluations available were included in the analysis.
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.
Outcome measures
| Measure |
Isovue 250 VAS Score Prior to Injection (Baseline)
n=77 Participants
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).
|
Isovue 250 VAS Score Immediately After Injection
n=82 Participants
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).
|
Visipaque 270 VAS Score Prior to Injection (Baseline)
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).
|
Visipaque 270 VAS Score Immediately After Injection
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).
|
|---|---|---|---|---|
|
The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
|
75 participants
|
82 participants
|
—
|
—
|
Adverse Events
Isovue 250
Visipaque 270
Serious adverse events
| Measure |
Isovue 250
n=84 participants at risk
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).
|
Visipaque 270
n=85 participants at risk
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).
|
|---|---|---|
|
Vascular disorders
Aortic rupture
|
1.2%
1/84 • Number of events 1 • Start of investigational product administration through the follow-up period of 1 hour post-injection
|
0.00%
0/85 • Start of investigational product administration through the follow-up period of 1 hour post-injection
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/84 • Start of investigational product administration through the follow-up period of 1 hour post-injection
|
1.2%
1/85 • Number of events 1 • Start of investigational product administration through the follow-up period of 1 hour post-injection
|
|
Vascular disorders
Peripheral arterial dissection
|
1.2%
1/84 • Number of events 1 • Start of investigational product administration through the follow-up period of 1 hour post-injection
|
0.00%
0/85 • Start of investigational product administration through the follow-up period of 1 hour post-injection
|
Other adverse events
| Measure |
Isovue 250
n=84 participants at risk
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).
|
Visipaque 270
n=85 participants at risk
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).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
6/84 • Number of events 6 • Start of investigational product administration through the follow-up period of 1 hour post-injection
|
1.2%
1/85 • Number of events 1 • Start of investigational product administration through the follow-up period of 1 hour post-injection
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. For one site, there is a Clinical Trial Cooperative Research and Development Agreement (CRADA) with a restriction of 180 days after pooled data set is published by the sponsor or 180 after data lock of the complete data.
- Publication restrictions are in place
Restriction type: OTHER