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Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral (DSA)
This study is currently recruiting participants.
Verified by Bracco Diagnostics, Inc, January 2009
Sponsored by: Bracco Diagnostics, Inc
Information provided by: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT00740207
  Purpose

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

Drug Information available for: Iodixanol Iopamidol
U.S. FDA Resources
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)

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • To compare pain in the lower extremities following intraarterial administration of ISOVUE-250 and VISIPAQUE 270 in peripheral DSA. [ Time Frame: During Procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the motion artifact and requirement for repeat injection(s) following intraarterial administration of ISOVUE-250 and VISIPAQUE 270 in peripheral DSA. [ Time Frame: During Procedure ] [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Enroll a patient in this study if the patient meets the following inclusion criteria:

  • Provides written Informed Consent and is willing to comply with protocol requirements;
  • Is at least 18 years of age;
  • Is scheduled to undergo peripheral DSA for the diagnosis and/or treatment (PTA) of PAOD.

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:

  • Is a pregnant or lactating female. Exclude the possibility of pregnancy:
  • by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of investigational product administration,
  • by surgical history (e.g., tubal ligation or hysterectomy),
  • post menopausal with a minimum 1 year without menses;
  • Has any known allergy to one or more of the ingredients of the investigational products;
  • Has a history of severe congestive heart failure [class IV in accordance with the classification of the New York Heart Association (NYHA)]
  • Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
  • Has a history of hypersensitivity to iodinated contrast agents;
  • Has renal impairment (eGFR <60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease [MDRD] study equation , );
  • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00740207

Contacts
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

Locations
United States, New Jersey
Bracco Diagnostics Inc. Recruiting
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Chair: Steven N. Sireci, MD Bracco Diagnostics, Inc
  More Information

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

Study placed in the following topic categories:
Arterial Occlusive Diseases
Vascular Diseases
Pain

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009