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

Peripheral Arterial Occlusive Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740207
• Other study ID #: IOP-113
• Status: Completed
• Phase: Phase 4
• First received: August 20, 2008
• Last updated: May 5, 2011
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: May 2011
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare ISOVUE-250 and VISIPAQUE 270 for motion artifact and pain following intraarterial injection for peripheral DSA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ßHCG) 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.

Study Design

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Intervention

Drug:
• VISIPAQUE 270
VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
• Isovue 250
ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Immediately prior to power injection run and again immediately following power injection run	Yes
Secondary	The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.	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.	Immediately postdose	No
Secondary	The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.	The Investigator assessed the images and recorded the number of repeat power injections required due to motion artifacts for each participant.	Immediately postdose	No