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

Bracco

Status and phase

Completed

Phase 4

Conditions

Peripheral Arterial Occlusive Disease

Treatments

Drug: VISIPAQUE 270

Drug: Isovue 250

Study type

Interventional

Funder types

Industry

Identifiers

NCT00740207

IOP-113

Details and patient eligibility

About

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

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.