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A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide

This study has been completed.
Information provided by:
GE Healthcare Identifier:
First received: September 13, 2005
Last updated: October 30, 2007
Last verified: October 2007

Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body.

Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using MR.

The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.

Condition Intervention Phase
Renal Artery Stenosis Drug: Gadodiamide Injection Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: GEHC Has Decided Not to Provide This Detail But Will Rely on the Brief Title

Resource links provided by NLM:

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Subject level efficacy of CE-MRA in detecting stenosis (50% occlusion) of major renal arteries. IA-DSA is the truth standard.

Secondary Outcome Measures:
  • Subject and vessel level efficacy comparison of CE-MRA and TOF-MRA in detecting stenosis, accessing arteries and diagnosis; Efficacy of CE-MRA and TOF-MAR combined; Clinical utility; Safety

Estimated Enrollment: 270
Study Start Date: September 2003
Detailed Description:
GEHC has decided not to provide this detail.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Study Subjects must be adults with confirmed or suspected Renal Artery stenosis.
  • The subject must have been referred for Digital Subtraction Angiography.

Exclusion Criteria:

  • The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR contrast media including, but not restricted to, the investigational product.
  • The subject is lactating.
  • The subject is pregnant as defined by a serum or urine β-HCG pregnancy test obtained within 24 hours before investigational product administration.
  • The subject has received or is scheduled to receive MRI contrast medium within 24 h prior to or less than 24 hours after the investigational product administration.
  • The subject has received or is scheduled to receive X-ray contrast medium within 7 days prior to or less than 24 hours after administration of investigational product.
  • The subject has received an investigational product within 30 days prior to or will receive an investigational product less than 24 hours after investigational product administration.
  • The subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months.
  • The subject has had a percutaneous transluminal angioplasty (PTA) in the renal region performed within 4 weeks prior to investigational product administration.
  • The subject has a stent in the renal arteries.
  • The subject has had a kidney transplantation.
  • The subject has a serum creatinine value of >3.5 mg/dL (309.4 µmol/L).
  • The subject has previously been included in this study.
  • The subject has a contra-indication for MRI according to accepted clinical guidelines.
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Please refer to this study by its identifier: NCT00209391

Amersham Buchler GmbH & Co. KG
Ismaning, Germany
Sponsors and Collaborators
GE Healthcare
Study Director: Michael Karl, PhD GE Healthcare
  More Information Identifier: NCT00209391     History of Changes
Other Study ID Numbers: SOV301
Study First Received: September 13, 2005
Last Updated: October 30, 2007

Keywords provided by GE Healthcare:
Renal Artery Stenosis
Diagnostic Imaging
Magnetic Resonance Angiography
Contrast Media

Additional relevant MeSH terms:
Renal Artery Obstruction
Kidney Diseases
Urologic Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 21, 2017