NL-OMON56490尚未招募不适用
The Use of Intravascular Ultrasound (IVUS) in Below-The-Knee (BTK) Arteries: A Randomized Controlled Trial. - TIBA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 52
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
- •* Age >18 years old;
- •* CLTI, defined as the presence of PAD in combination with rest pain, gangrene,
- •or a lower limb ulceration >2 weeks duration;
- •* Indication for BTK endovascular revascularization, as set by the
- •multidisciplinary team;
- •* De novo vascular target lesion;
- •* Written informed consent.
排除标准
- •* Target lesions with a length of <5 cm or >20 cm;
- •* Kawarada Type III pedal arch (no patent dorsalis pedis artery, no patent
- •plantar artery);
- •* Below-the-knee (BTK) critical limb ischemia (CLTI) based on acute thrombosis
- •or thrombo-emboli;
- •* Renal insufficiency with a glomerular filtration rate (GFR) of less than 15
- •ml/min but not on dialysis;
- •* Contrast allergy;
- •* Non-salvageable limbs due to extensive tissue necrosis or infection
- •(Rutherford classification of chronic limb ischemia 6 or WiFi classification
- •wound score 3);
- •* ASA-classification of IV or higher;
- •* Ejection fraction <30%;
- •* MAC score >2;
- •* Target lesions not amenable for endovascular treatment by operators* decision
- •after baseline angiography (Angio-1);
- •* Pregnancy.
研究者
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