A Safety and Efficacy Clinical Study to Evaluate the Narrowing of the Aorto-iliac Arteries While Using Gadodiamide

NCT00209443 | Completed Phase 3

• 1 other identifier: SOV302
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aorto-iliac Stenosis; Arterial Occlusive Diseases

Keywords

Aorto-iliac Stenosis; Occlusion; Diagnostic Imaging; Omniscan; Magnetic Resonance Angiography; Contrast Media

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Gadodiamide Injection

EXPERIMENTAL

All subjects received a single intravenous bolus injection via a power injector of Omniscan (Gadodiamide Injection) at a dose of 0.1 mmol/kg

Drug: Gadodiamide Injection

Interventions

Gadodiamide Injection DRUG

Also known as: Omniscan

Gadodiamide Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study subjects must be adults with confirmed or suspected aorto-iliac stenosis.
• The subject must have been referred for Digital Subtraction Angiography.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Amersham Buchler GmbH & Co. KG

Ismaning, Germany

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases; Bites and Stings

Interventions

gadodiamide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Michael Karl

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2004
• Primary Completion: February 28, 2006
• Study Completion: February 28, 2006
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

DE (1)