DRKS00015856已完成不适用
Endovascular Treatment of Patients with Critical Limb Ischemia - GIKEI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
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.
- •11. Unable to adhere to the study protocol.
- •12. Severe concomitant condition or disease (e.g. life expectancy <6 months, dementia or advanced liver disease).
研究者
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