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

• Conditions: Suspected or proven chronic PAOD predominantly located in the aorto-iliac region of Fontaine Stages IIb to IV (ie, Rutherford Stages I3-III), or presents with an ankle brachial pressure index of <0.70 (measured no more than 3 months prior to screening); MedDRA version: 7.0Level: LLTClassification code 10062585

• Registration Number: EUCTR2004-000994-69-AT
• Lead Sponsor: Amersham Buchler GmbH & Co KG an affiliate of GE Healthcare Bio-Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-07
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

(1)The subject has suspected or proven chronic PAOD predominantly located in the aorto-iliac region of Fontaine Stages IIb to IV (ie, Rutherford Stages I3-III), or presents with an ankle brachial pressure index of <0.70 (measured no more than 3 months prior to screening).
(2)The subject has been referred to IA DSA for determination of subject management (no more than 1 month prior to inclusion).
(3)The subject has had no intervention or change of symptoms within the region of interest (ROI) between 3D CE MRA and IA DSA.
(4)The subject is 18 years or older.
(5)The subject is conscious and able to comply with study procedures.
(6)Written and dated (ie, date and time) informed consent is obtained.
(7)If the subject is a woman of childbearing potential, the results of a serum or urine human chorionic gonadotropin (ß-HCG) pregnancy test, done at screening within 24 hours before dosing (with the result known before investigational product administration), must be negative. Only those women who are surgically sterile (have had a documented bilateral oophorectomy and/or documented hysterectomy) or post-menopausal (cessation of menses for more than for more than 1 year) will be allowed to enrol in the study without a pregnancy test at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

(1)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.
(2)The subject is lactating.
(3)The subject is pregnant as defined by a serum or urine ß-HCG pregnancy test obtained within 24 hours before administration of the investigational product.
(4)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.
(5)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.
(6)The subject received an investigational product other than OMNISCAN within 30 days prior to OMNISCAN administration or will receive an investigational product within the follow-up period proposed for this study.
(7)The subject presents any clinically active, serious, life-threatening disease with a life expectancy of less than 6 months.
(8)The subject has a serum creatinine value of >3.5 mg/dL (309.4 µmol/L).
(9)The subject has previously been included in this study.
(10)The subject has a contra-indication for MRI according to accepted clinical guidelines.
(11) The subject has metal implants and/or stents in the aorto-iliac region and/or hip replacement.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified