NCT00768495Unknown不适用
Evaluation of the Success of Endovascular Peripheral Revascularization for the Treatment of Chronic Limb Ischemia by Measuring OxyHb and DeoxyHb Using a New Hyperspectral Imaging Device (OxyVu).
HyperMed1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This trial will collect tissue oxygenation data via hyperspectral imaging before and after endovascular procedures.
详细描述
This will be a nonrandomized, nonblinded, prospective observational study to correlate the results obtained with the traditional measures of success of endovascular revascularization of peripheral arteries for the treatment of chronic limb ischemia; i.e., ABPI, PVR with oxyhemoglobin (OxyHb) and deoxyhemoglobin (DeoxyHb) measurements obtained with a new imaging device manufactured by HyperMed Inc (OxyVu) that uses hyperspectral technology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with established diagnosis of lower limb ischemic based on their symptoms of claudication, rest pain, non-healing ulcers or gangrene and other vascular laboratory tests that are currently used to make this diagnosis and have been scheduled for endovascular revascularization.
- •Age group between 50-85
- •Gender - Male or Female
- •Race - all race and ethnicities
排除标准
- •Patients with known cardiac disease - new MI (within 3 months).
- •Patients with hypertension with the systolic BP >200 or diastolic BP>110 on the day of testing
- •Patients on supplemental O2 for chronic obstructive lung disease
- •Bed-ridden subjects - either due to chronic disability or neurological problems
研究者
研究点 (1)
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