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Isovue in Peripheral Digital Subtraction Angiography (DSA)

Primary Purpose

Peripheral Arterial Occlusive Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
iopamidol
iodixanol
Sponsored by
Bracco Diagnostics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Occlusive Disease focused on measuring Peripheral arterial occlusive disease (PAOD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bracco Diagnostics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isovue 250 (iopamidol)

Visipaque 270 (iodixanol)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 23, 2010
Last Updated
May 23, 2013
Sponsor
Bracco Diagnostics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01075217
Brief Title
Isovue in Peripheral Digital Subtraction Angiography (DSA)
Official Title
A Phase IV Multi-Center Study to Compare ISOVUE -250 and VISIPAQUE 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bracco Diagnostics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease
Keywords
Peripheral arterial occlusive disease (PAOD)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isovue 250 (iopamidol)
Arm Type
Experimental
Arm Title
Visipaque 270 (iodixanol)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
iopamidol
Other Intervention Name(s)
Other name: Isovue 250
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
iodixanol
Other Intervention Name(s)
Other name: Visipaque 270
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
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.
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. Scores of 3 and 4 were counted as significant motion artifacts.
Time Frame
Immediately postdose
Title
The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.
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
Title
The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Krix, M.D.
Organizational Affiliation
Bracco Diagnostics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Bracco Diagnostics
City
Princeton
State/Province
New Jersey
Country
United States

12. IPD Sharing Statement

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Isovue in Peripheral Digital Subtraction Angiography (DSA)

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