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

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:

Drug Information available for: Iopamidol Iodixanol

U.S. FDA Resources

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 May 16, 2013