Pilot Study to Compare ISOVUE®-250 and VISIPAQUE™ 270 for Motion Artifact and Pain in Peripheral DSA

This study has been completed.
Sponsor:
Information provided by:
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT00740207
First received: August 20, 2008
Last updated: May 5, 2011
Last verified: May 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • Level of Pain in the Lower Extremities Scored by the Participants on the Visual Analog Scale Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA. [ Time Frame: Immediately prior to power injection run and again immediately following power injection run ] [ Designated as safety issue: Yes ]
    Visual Analog Scale: Patients were asked to mark on a 10 centimeter line where their pain was in the lower extremity of interest, in relation to the 2 extremes: no pain (0) on the far left and worst pain (10) on the far right. Pain Severity Scale: (0) None = VAS Score 0; (1) Mild = VAS Score 1-3; (2) Moderate = VAS Score 4-6; (3) Severe = VAS Score 7-10. Patients were assessed immediately prior to injection and again immediately following injection.


Secondary Outcome Measures:
  • The Number of Participants With Motion Artifacts 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.

  • 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.


Enrollment: 33
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Isovue 250 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
Other Name: Iopamidol Injection
Active Comparator: VISIPAQUE 270 Drug: VISIPAQUE 270
VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
Other Name: Iodixanol Injection

  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

Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
Study Chair: Steven N. Sireci, MD Bracco Diagnostics, Inc
  More Information

No publications provided

Responsible Party: Carmela Houston/ Sr. Manager Corporate Clinical Research, Bracco Diagnostics
ClinicalTrials.gov Identifier: NCT00740207     History of Changes
Other Study ID Numbers: IOP-113
Study First Received: August 20, 2008
Results First Received: September 13, 2010
Last Updated: May 5, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014