Isovue in Peripheral Digital Subtraction Angiography (DSA)

• ClinicalTrials.gov Identifier: NCT01075217
• Recruitment Status: Completed
• First Posted: February 25, 2010
• Results First Posted: May 23, 2013
• Last Update Posted: May 30, 2013
• Sponsor: Bracco Diagnostics, Inc
• Information provided by (Responsible Party): Bracco Diagnostics, Inc

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Occlusive Disease	Drug: iopamidol; Drug: iodixanol	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 174 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• 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 Start Date: April 2010
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Isovue 250 (iopamidol)	Drug: iopamidol; 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).; Other Name: Other name: Isovue 250
Active Comparator: Visipaque 270 (iodixanol)	Drug: iodixanol; 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).; Other Name: Other name: Visipaque 270

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 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 Outcome Measures :

1. 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 [ Time Frame: 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.

2. 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. [ Time Frame: 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.
3. The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. [ Time Frame: Immediately postdose ]
   The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.
4. The Number of Participants With Adequate Quality of Opacification Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New Jersey

Bracco Diagnostics

Princeton, New Jersey, United States

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

• Study Director: Martin Krix, M.D.; Bracco Diagnostics, Inc

More Information

• Responsible Party: Bracco Diagnostics, Inc
• ClinicalTrials.gov Identifier: NCT01075217
• Other Study ID Numbers: IOP 119
• First Posted: February 25, 2010
• Results First Posted: May 23, 2013
• Last Update Posted: May 30, 2013
• Last Verified: April 2012

Keywords provided by Bracco Diagnostics, Inc:

Peripheral arterial occlusive disease (PAOD)

Additional relevant MeSH terms:

Arterial Occlusive Diseases; Peripheral Arterial Disease; Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Peripheral Vascular Diseases