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Isovue in Peripheral Digital Subtraction Angiography (DSA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01075217
First received: February 23, 2010
Last updated: May 23, 2013
Last verified: April 2012
  Purpose

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 Intervention Phase
Peripheral Arterial Occlusive Disease
Drug: iopamidol
Drug: iodixanol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

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 [ Time Frame: immediately after administration of agent using a power injector for the administration ] [ Designated as safety issue: No ]

    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 [ Time Frame: Immediately after administration of agent using a power injector for the administration ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 174
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075217

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

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01075217     History of Changes
Other Study ID Numbers: IOP 119
Study First Received: February 23, 2010
Results First Received: February 25, 2013
Last Updated: May 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Bracco Diagnostics, Inc:
Peripheral arterial occlusive disease (PAOD)

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases
Iodixanol
Iopamidol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 24, 2014