NL-OMON35325已完成不适用
Dutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thrombo-embolic infra-inguinal disease. - DUET study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patients with recently (between 1 and 7 weeks) thrombosed femoro-popliteal or femoro-crural native arteries with ischemic complaints.
- •2. Patients with recently (between 1 and 7 weeks) thrombosed femoro-popliteal or femoro-crural venous or prosthetic bypass grafts with ischemic complaints.
- •3. Limb ischemia class I and IIa according to the Rutherford classification for acute ischemia.
- •4. Patients >18 years and < 85 years old.
- •5. 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 localized (<5 cm) emboli / occlusions in the native femoropopliteal arteries
- •3. Patients with clinical complaints of lower limb ischemia due to thrombosis of the native femoro-crural arteries or femoro-popliteal and femoro-crural bypass grafts <1 week and >7 weeks.
- •4. Patients with acute lower limb ischemia class IIb and III according to the Rutherford classification (see below).
- •5. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- •6. Recent (< 6 weeks) ischemic stroke or cerebral bleeding
- •7. Patients with recent (<6 weeks) surgery
- •8. Severe hypertension (diastolic blood pressure >110 mmHg, systolic blood pressure >200 mmHg)
- •9. Current malignancy
- •10. Patients with a history of prior life-threatening contrast medium reaction
- •11. Patients with uncorrected bleeding disorders (GI ulcera, mennorrhagia, liver failure)
- •12. Female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding.
- •13. Pregnancy
- •14. Any patient considered to be hemodynamically 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 < 18 years or >85 years old.
- •18. Severe co-morbid condition with life expectancy < 1 month
- •19. Contra-indication for MRI
研究者
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