Arterial Occlusive Diseases Clinical Trial
Official title:
A Multicentre, Phase 3, Open-Label Study to Assess the Efficacy and Safety of 0.1 mmol/kg Omniscan (Gadodiamide Injection) for Magnetic Resonance Angiography (MRA) of the Aorto-iliac Arteries
Verified date | April 2019 |
Source | GE Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 aorto-iliac 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 aorto-iliac arteries. Intra-arterial Digital Subtraction
Angiography (IADSA) will be used as the standard of truth.
Status | Completed |
Enrollment | 407 |
Est. completion date | February 28, 2006 |
Est. primary completion date | February 28, 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Study subjects must be adults with confirmed or suspected aorto-iliac 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 beta-HCG pregnancy test obtained within 24 hours before administration of the investigational product. - The subject received or is scheduled to receive MRI contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product. - The subject received or is scheduled to receive X-ray contrast medium within 24 hours prior to or less than 24 hours after administration of the investigational product. - The subject received an investigational product other than OMNISCAN (gadodiamide) within 30 days prior to OMNISCAN administration or will receive an investigational product within the follow-up period proposed for this study. - The subject presents any clinically active, serious, life-threatening disease with a life expectancy of less than 6 months. - 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. - The subject has metal implants and/or stents in the aorto-iliac region and/or hip replacement. |
Country | Name | City | State |
---|---|---|---|
Germany | Amersham Buchler GmbH & Co. KG | Ismaning |
Lead Sponsor | Collaborator |
---|---|
GE Healthcare |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differences in subject level and vessel level sensitivity and specificity between CE-MRA and TOF-MRA in detecting stenosis,(>50% occlusion) in aorto-iliac arteries. IA-DSA is the truth standard. | 27 hours | ||
Secondary | Differences in sensitivity, specificity, accuracy, PPV and NPV at subject and/or vessel level between CE-MRA and TOF-MRA in detecting stenosis (50% occlusion) in aorta-iliac arteries; Revascularisation strategies based on CE-MRA, TOF-MRA and IA DSA | 27 hours |
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