NL-OMON50291招募中4 期
A randomized controlled trial comparing venous stenting with conservative treatment in patients with Deep Venous Obstruction - RCT in Treatment of Deep Venous Obstruction
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 130 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria:
- •-- Age >18 years
- •- Meet criteria for PTS
- •- Patients with May Thurner syndrome on additional imaging
- •- All patients with unilateral iliofemoral obstruction on radiological work up
- •expected to be treated solely percutaneous (without AV-fistula) based on post
- •thrombotic changes till above the femoral/ profundal confluents
- •- Life expectancy of more than one year
- •- Deep venous thrombosis > 1 year
- •- Signed informed consent
排除标准
- •- Previous intervention of central veins (inferior vena cava, iliac veins,
- •common femoral vein) on the affected limb
- •- Bilateral disease
- •- Known pregnancy
- •- Inability to answer Dutch QoL questionnaires
- •- Contra-indication for prolonged anticoagulant treatment
- •- Recent, <1 year, deep venous thrombosis or pulmonary Embolism
- •- Known contrast allergy
- •- Known dialysis
- •- Uncontrolled or active coagulopathy or known uncorrectable bleeding diathesis
- •- Hypersensitivity to nitinol or nickel
- •- Known to be, or suspected of being unable to comply with the study protocol
- •(e.g. no permanent address, known to be non-compliant or presenting an unstable
- •psychiatric history)
- •- Legal incapacity and/or other circumstances rendering the subject unable to
- •understand the nature, scope and possible impact of the study
- •- Subjects in custody by juridical order
- •- Subjects who do not agree to the transmission of their pseudonymous data
- •within the liability of documentation and notification
- •- Close affiliation with the investigational site: e.g. a close relative of the
- •investigator or a possibly dependent person (e.g. employee or student of the
- •investigational site)
研究者
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