Isovue in Peripheral Digital Subtraction Angiography (DSA)

Phase 4

Completed

• Conditions: Peripheral Arterial Occlusive Disease
• Interventions: Drug: iopamidol; Drug: iodixanol

• Registration Number: NCT01075217
• Lead Sponsor: Bracco Diagnostics, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Study Start: 2010-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-04
• Results First Submitted: 2013-02-25
• Results First Submitted QC: 2013-04-15
• Results First Posted: 2013-05-23
• Last Update Submitted: 2013-05-23
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isovue 250 (iopamidol)	iopamidol	-
Visipaque 270 (iodixanol)	iodixanol	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Bracco Diagnostics; 🇺🇸 Princeton, New Jersey, United States