A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-Iliac Arteries While Using Gadodiamide
This study has been completed.
Sponsor:
GE Healthcare
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00209443
First received: September 13, 2005
Last updated: October 30, 2007
Last verified: October 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Aorto-Iliac Stenosis Arterial Occlusive Diseases |
Drug: Gadodiamide Injection |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
Resource links provided by NLM:
Further study details as provided by GE Healthcare:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 295 |
| Study Start Date: | September 2004 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00209443 History of Changes |
| Other Study ID Numbers: | SOV302 |
| Study First Received: | September 13, 2005 |
| Last Updated: | October 30, 2007 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada European Union: European Medicines Agency |
Keywords provided by GE Healthcare:
|
Aorto-iliac Stenosis Occlusion Diagnostic Imaging |
Omniscan Magnetic Resonance Angiography Contrast Media |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Constriction, Pathologic Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 16, 2013