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

NCT00740207 | Completed Phase 4 Results

• 1 other identifier: IOP-113
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• The Number of Participants With Motion Artifacts Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.

  Immediately postdose

• The Number of Participants Requiring Repeat Injection(s) Following Intraarterial Administration of ISOVUE-250 or VISIPAQUE 270 in Peripheral DSA.

  Immediately postdose

Study Arms (2)

Isovue 250

ACTIVE COMPARATOR

Drug: Isovue 250

VISIPAQUE 270

ACTIVE COMPARATOR

Drug: VISIPAQUE 270

Interventions

VISIPAQUE 270 DRUG

VISIPAQUE 270 (Iodixanol Injection) is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution

Also known as: Iodixanol Injection

VISIPAQUE 270

Isovue 250 DRUG

ISOVUE-250 (Iopamidol Injection) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution

Also known as: Iopamidol Injection

Isovue 250

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Interventions

iodixanol; Iopamidol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Usha Halemane
• Organization: Bracco Diagnostics Inc.

usha.halemane@diag.bracco.com

609-514-2578

Study Officials

• Steven N. Sireci, MD

  Bracco Diagnostics, Inc

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 22, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 9, 2011
• Results First Posted: April 18, 2011

Record last verified: 2011-05