DRKS00015856
已完成
不适用
Endovascular Treatment of Patients with Critical Limb Ischemia - GIKEI
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- I70.25
- 发起方
- GRN Klinik Weinheim
- 入组人数
- 50
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Patients with PAD and critical limb ischemia.
排除标准
- •1\. Fontaine Stages I or IIa without indication for endovascular treatment.
- •2\. Acute limb\-threatening ischemia of iliac and femoral arteries with indication for treatment with heparin, low\-molecular heparins, new anticoagulants or cumadin.
- •3\. Candidates requiring surgical revascularization or hybrid procedures after failed endovascular treatment
- •4\. Severe renal failure, creatinine clearance \<30 mL/min
- •5\. Platelet count \<100x109/L
- •6\. Anemia with Hb\<10\.0 g/dL
- •7\. History of or condition associated with increased bleeding risk including: trauma within 30 days before the index procedure, clinically significant gastrointestinal bleeding within the last 6 months, history of apoplexy within the last 3 months, fibrinolytics within 10 days before the index procedure, intracranial, intraocular, spinal, or atraumatic intra\-articular bleeding, chronic hemorrhagic disorder, known intracranial neoplasm, arteriovenous malformation, or aneurysm, sustained uncontrolled hypertension: systolic blood pressure \=180 mmHg or diastolic blood pressure \=100 mmHg, known significant liver disease (e.g., acute clinical hepatitis, liver cirrhosis)
- •8\. Alcohol or drug abuse within 12 months before the index procedure.
- •9\. Pregnancy, breast feeding or childbearing potential without proper contraceptive measures.
- •10\. Indication for anticoagulation or dual platelet treatment due to atrial fibrillation, aortic valve replacement, vein thrombosis, acute coronary syndrome etc.
结局指标
主要结局
未指定
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