ISRCTN72676102已完成不适用
Dutch randomised trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thromboembolic infra-inguinal disease (DUET)
St Antonius Hospital Nieuwegein (Netherlands)0 个研究点目标入组 60 人开始时间: 2009年12月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1. Both males and females, greater than 18 years and less than 85 years old
- •2. Patients with recently (between 1 and 7 weeks) thrombosed femoro-popliteal or femoro-crural native arteries or femoro-popliteal or femoro-crural venous or prosthetic bypass grafts with ischaemic complaints
- •3. Patients with acute lower limb ischaemia class I and IIa according to the Rutherford classification
- •4. Patients understand the nature of the procedure and provide written informed consent, prior to enrolment in the study
排除标准
- •1. Patients with isolated common femoral artery thrombosis including the origin of the superficial femoral artery and profunda femoral artery
- •2. Patients with localised (less than 5 cm) emboli/occlusions in the native femoro-popliteal arteries
- •3. Patients with clinical complaints of acute lower limb ischaemia due to thrombosis of the femoro-popliteal or femoro-crural native arteries or femoro-popliteal or femoro-crural venous or prosthetic bypass grafts less than 1 week and greater than 7 weeks
- •4. Patients with acute lower limb ischaemia class IIb and III according to the Rutherford classification
- •5. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contra-indicated
- •6. Recent (less than 6 weeks) ischaemic stroke or cerebral bleeding
- •7. Patients with recent (less than 6 weeks) surgery
- •8. Severe hypertension (diastolic blood pressure greater than 110 mmHg, systolic blood pressure greater than 200 mmHg)
- •9. Current malignancy
- •10. Patients with a history of prior life-threatening contrast medium reaction
- •11. Patients with uncorrected bleeding disorders (gastro-intestinal ulcer, menorrhagia, liver failure)
- •12. Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding
- •13. Pregnancy
- •14. Any patient considered to be haemodynamically unstable at onset of procedure
- •15. Patients refusing treatment
- •16. Patients currently participating in another investigational drug or device study that have not completed the entire follow up period
- •17. Patients less than 18 years or greater than 85 years old
- •18. Severe co-morbid condition with life expectancy less than 1 month
- •19. Contra-indication for magnetic resonance imaging (MRI)
研究者
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