EUCTR2007-003762-18-FR进行中（未招募）不适用
Prospective monocenter accuracy study of Vasovist? contrast enhanced magnetic resonance venography (CE-MRV) to detect venous thrombi in patients with Ultrasonography detected peripheral acute deep venous thrombosis (DVT) in at least one vessel
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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 with recent positive DVT by USCD.
- •2. Patients who have no contra indication to be screened by MRI
- •3. Patients who have no contra-indication against the IV injection of Vasovist
- •4. Patients who have given their fully informed and written consent voluntarily.
- •5. The subject must be covered by a social security system.
- •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. Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study
- •3. Having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
- •4. If USCD is performed > 48 hours prior to Vasovist®-MRV.
- •5. Not being able to remain lying down for at least 45 – 60 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
- •6. Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
- •7. Hypersensitivity to the active substance or to any of the excipients of Vasovist®
- •8. Being clinically unstable and whose clinical course during the 24 (+ 4) hours observation period is unpredictable.
- •9. Having any contraindication to MRI examination or specifically for MRV (e.g. pacemaker, recent wound clips, and severe claustrophobia).
- •10. Renal insufficiency, whatever is the stage.
- •11. Hepatic insufficiency.
- •12. The patients having already undergone an injection of Gadolinium.
- •13. Pregnant women or women breast feeding.
- •14. Presence of a stent or vascular filter on the examined sites.
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