Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Diagnostic
Condition:	Peripheral Arterial Occlusive Disease
Interventions:	Drug: VISIPAQUE 270 Drug: Isovue 250

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first patient to participate in this study was dosed on September 17, 2008; the last patient on June 15, 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

Description

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).

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).

Participant Flow: Overall Study

	ISOVUE 250	VISIPAQUE 270
STARTED	17	16
COMPLETED	17	16
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
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).
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).
Total	Total of all reporting groups

Baseline Measures

	ISOVUE 250	VISIPAQUE 270	Total
Number of Participants [units: participants]	17	16	33
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	6	7	13
>=65 years	11	9	20
Age [units: years] Mean ± Standard Deviation	65.9 ± 9.42	66.9 ± 9.93	66.4 ± 9.53
Gender [units: participants]
Female	11	10	21
Male	6	6	12
Region of Enrollment [units: participants]
United States	7	6	13
Canada	10	10	20

Outcome Measures

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1. 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. [ Time Frame: Immediately prior to power injection run and again immediately following power injection run ]

Measure Type	Primary
Measure 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.
Measure 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
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who did not deviate from the planned protocol.

Reporting Groups

	Description
VAS Score Prior to Injection of ISOVUE 250	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.
VAS Score After Injection of 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).
VAS Score Prior to Injection of VISIPAQUE 270	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.
VAS Score After Injection of 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).

Measured Values

	VAS Score Prior to Injection of ISOVUE 250	VAS Score After Injection of ISOVUE 250	VAS Score Prior to Injection of VISIPAQUE 270	VAS Score After Injection of VISIPAQUE 270
Number of Participants Analyzed [units: participants]	10	10	10	10
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. [units: Participants]
(0) None	8	6	7	2
(1) Mild	0	1	1	7
(2) Moderate	2	3	2	1
(3) Severe	0	0	0	0

Statistical Analysis 1 for 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.

Groups ^[1]	VAS Score After Injection of ISOVUE 250 vs. VAS Score After Injection of VISIPAQUE 270
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.7142
Mean Difference (Final Values) ^[4]	-0.2
95% Confidence Interval	( -1.3 to 0.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Paired t-test to compare difference between the investigational product's mean change from predose to postdose
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

2. Secondary:

The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. [ Time Frame: Immediately postdose ]

Measure Type	Secondary
Measure Title	The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients who did not deviate from the planned protocol.

Reporting Groups

Description

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).

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).

Measured Values

	ISOVUE 250	VISIPAQUE 270
Number of Participants Analyzed [units: participants]	10	10
The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. [units: Participants]
(0) No Motion Artifacts	8	4
(1) Mild, Not significant	1	5
(2) Significant, But Correctable	1	1
(3) Degrades Image Quality	0	0
(4) Images Uninterpretable	0	0

Statistical Analysis 1 for The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	0.1698
Mean Difference (Final Values) ^[4]	-40.0
95% Confidence Interval	( -79.2 to -0.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Paired t-test to compare the difference in percentage between the portions of patients who had motion artifacts.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. [ Time Frame: Immediately postdose ]

Measure Type	Secondary
Measure Title	The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

Description

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).

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).

Measured Values

	ISOVUE 250	VISIPAQUE 270
Number of Participants Analyzed [units: participants]	10	10
The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. [units: Participants]	0	1

Statistical Analysis 1 for The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.

Groups ^[1]	All groups
Method ^[2]	Fisher Exact
P Value ^[3]	1.000
Mean Difference (Final Values) ^[4]	-10.0
95% Confidence Interval	( -28.6 to 8.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Paired t-test to compare difference in percentage between the number of participants requiring repeat injections
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	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. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The results of the study may be presented during scientific symposia or published in a scientific journal only after review by Bracco in accordance with the guidelines set forth in the applicable publication or financial agreement.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Usha Halemane
Organization: Bracco Diagnostics Inc.
phone: 609-514-2578
e-mail: usha.halemane@diag.bracco.com

No publications provided

Responsible Party:	Carmela Houston/ Sr. Manager Corporate Clinical Research, Bracco Diagnostics
ClinicalTrials.gov Identifier:	NCT00740207 History of Changes
Other Study ID Numbers:	IOP-113
Study First Received:	August 20, 2008
Results First Received:	September 13, 2010
Last Updated:	May 5, 2011
Health Authority:	United States: Institutional Review Board