EUCTR2004-000994-69-AT进行中（未招募）不适用
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
Amersham Buchler GmbH & Co KG an affiliate of GE Healthcare Bio-Sciences0 个研究点目标入组 192 人开始时间: 2004年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 192
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(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
排除标准
- •(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.
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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 arteriesSuspected 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 10062585EUCTR2004-000994-69-BEAmersham Health192
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