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Sponsored by: |
Bracco Diagnostics, Inc |
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Information provided by: | Bracco Diagnostics, Inc |
ClinicalTrials.gov Identifier: | NCT00740207 |
The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.
Condition | Intervention | Phase |
---|---|---|
Peripheral Arterial Occlusive Disease |
Drug: VISIPAQUE 270 Drug: Isovue 250 |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase IV Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA) |
Estimated Enrollment: | 20 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Isovue 250: Active Comparator |
Drug: Isovue 250
ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
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VISIPAQUE 270: Active Comparator |
Drug: VISIPAQUE 270
VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Enroll a patient in this study if the patient meets the following inclusion criteria:
Exclusion Criteria:
Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:
Contact: Carmela Houston, M.S. | 516-333-8230 ext 3350 | carmela.houston@diag.bracco.com |
Contact: Steven N Sireci, M.D. | 609-514-2223 | Steve.Sireci@diag.bracco.com |
United States, New Jersey | |
Bracco Diagnostics Inc. | Recruiting |
Princeton, New Jersey, United States, 08540 |
Study Chair: | Steven N. Sireci, MD | Bracco Diagnostics, Inc |
Responsible Party: | Bracco Diagnostics ( Carmela Houston/ Sr. Manager Corporate Clinical Research ) |
Study ID Numbers: | IOP-113 |
Study First Received: | August 20, 2008 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00740207 |
Health Authority: | United States: Institutional Review Board |
Arterial Occlusive Diseases Vascular Diseases Pain |
Cardiovascular Diseases |