EUCTR2007-006014-41-DE进行中（未招募）不适用
Determination of Diagnostic Accuracy and Added Value of Vasovist®-Enhanced Peripheral MRA in Comparison to Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients with Peripheral Artery Disease
niversity Heidelberg, University Hospital Mannheim0 个研究点目标入组 145 人开始时间: 2008年2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
- 145
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. Patients who have Fontaine-stage III and IV and an indication for therapeutic i.a. DSA
- •2. PAOD has to be confirmed by ECCM MRA, CTA, non-selective DSA, digital ultra¬sound (DUS) prior to the study.
- •3. Patients who are willing to undergo the study MRA procedure with Vasovist.
- •4. Patients who are willing to comply with the study procedures (e.g. being followed-up for 12 hours after the Vasovist? injection).
- •5. Patients who have given their fully informed and written consent voluntarily.
- •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. Being less than 18 years of age.
- •2. Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same day as administration of Vasovist. The manufacturer’s instructions for performing the urinary pregnancy test are to be followed.
- •3. Patients who are scheduled for any therapy between any of the two procedures that in¬terferes with the comparability of the two angiographic procedures.
- •4. Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
- •5. Having any physical or mental status that interferes with the informed consent proce¬dure including self-signed consent.
- •6. GFR < 30ml/m²/1.73m² (MDRD), values = 1 week or patients on hemodialysis
- •7. Renal or liver transplant patients, including patients with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF).
- •8. MR contraindications (pacemaker, magnetic clips, severe claustrophobia)
- •9. Known allergy to Gadofosveset
- •10.Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
- •11.Untreated significant stenosis in pelvis
- •12.Known severe coagulopathy (PTT >25s, Quick < 60%)
- •13.Having received any investigational drug within 7 days prior to entering this study or who are planned to receive any investigational drug during the safety follow-up pe¬riod.
- •14.Not being able to remain lying down for at least 30-45min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
- •15.Being clinically unstable and whose clinical course during the 12 hours observation period is unpredictable.
- •16.Being scheduled for, or likely to require, any surgical intervention within 12 hours be¬fore or within the follow-up period.
- •17.Patients in whom i.a. DSA is contra-indicated preventing him/her from undergoing standard of reference (SOR) procedure.
- •18.Close affiliation with the investigational site; e.g. a close relative of the investigator.
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