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Isovue in Peripheral Digital Subtraction Angiography (DSA)

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Bracco

Status and phase

Completed
Phase 4

Conditions

Peripheral Arterial Occlusive Disease

Treatments

Drug: iopamidol
Drug: iodixanol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01075217
IOP 119

Details and patient eligibility

About

No significant differences is expected in observed motion artifacts, heat or pain reported during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.

Enrollment

174 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • provides written informed consent;
  • at least 18 years of age;
  • scheduled to undergo peripheral DSA for the diagnosis and/or treatment of PAOD

Exclusion criteria

  • pregnant or lactating female;
  • known allergies to one more more ingredients in wither product;
  • history of severe congestive heart failure (Class IV);
  • previously enrolled or received an investigational compound within 30 days;
  • history of hypersensitivity to iodinated contrast agents;
  • renal impairment eGFR <60 mL/min/1.73m2, calculated using the MDRD study equation
  • any other medical condition decreasing chances of obtaining reliable data

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

174 participants in 2 patient groups

Isovue 250 (iopamidol)
Experimental group
Treatment:
Drug: iopamidol
Visipaque 270 (iodixanol)
Active Comparator group
Treatment:
Drug: iodixanol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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