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Isovue in Peripheral Digital Subtraction Angiography (DSA)

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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:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

February 23, 2010
February 25, 2010
February 25, 2013
May 23, 2013
May 30, 2013
April 2010
December 2011   (Final data collection date for primary outcome measure)
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.

comparison of pain in lower extremities following intraarterial administration of either contrast agent [ Time Frame: immediately after administration ]
Complete list of historical versions of study NCT01075217 on ClinicalTrials.gov Archive Site
  • 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.

  • 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.
  • 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.
  • 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.

Not Provided
Not Provided
Not Provided
 
Isovue in Peripheral Digital Subtraction Angiography (DSA)
A Phase IV Multi-Center Study to Compare ISOVUE -250 and VISIPAQUE 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)
No significant differences is expected in observed motion artifacts, heat or pain reported during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Peripheral Arterial Occlusive Disease
  • 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
  • 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
  • Experimental: Isovue 250 (iopamidol)
    Intervention: Drug: iopamidol
  • Active Comparator: Visipaque 270 (iodixanol)
    Intervention: Drug: iodixanol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
174
100
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01075217
IOP 119
No
Not Provided
Not Provided
Bracco Diagnostics, Inc
Bracco Diagnostics, Inc
Not Provided
Study Director: Martin Krix, M.D. Bracco Diagnostics, Inc
Bracco Diagnostics, Inc
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP