NL-OMON48610招募中不适用
Prospective Registration Of Critical Leg Ischemia Outcomes in the Netherlands - PROCLIO
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 502
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 至 99（—）
入选标准
- •Critical limb ischemia is defined as following;
- •Patients must have ischemic rest pain, tissue loss, ulcer or gangrene. Symptoms
- •have to be present for more than two weeks at time of enrollment. PAD must be
- •confirmed by one of the following;
- •* Absolute systolic ankle pressure < 70 mmHg
- •* Systolic Toe Pressure < 50 mmHg
- •* Transcutaneous oxygen pressure (tcPO2) < 50 mmHg
- •* One or more significant (>50%) obstructions in the iliac or lower limb
- •arteries as found with non-invasive imaging (duplex ultrasonography (DUS),
- •Magnetic Resonance Angiography (MRA), Computed Tomography Angiography (CTA)) or
- •digital subtraction angiography (DSA)
- •* Written informed consent
排除标准
- •In the case of meeting any of the following criteria patients will be excluded
- •from enrollment.
- •* Acute ischemia; due to emboli or trauma
- •* Non-atherosclerotic origin of ischemia; arteritis, thrombangitis obliterans
- •(Buerger*s disease)
- •* Hypercoagulable states
- •* Venous ulcer
- •* Insufficient proficiency of Dutch language, or inability to complete the
- •Dutch questionnaires
- •* In the case of bilateral affected limbs, the least affected limb will be
- •* Ipsilateral peripheral revascularization intervention of the affected limb
- •within the last three months before presentation
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