TRanslesIonal Assessment of Gradients During Endovascular Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures
研究概览
简要总结
Primary objective: To document change in translesional pressure gradients (TLPGs) and ratios (fractional flow reserve) using the NAVVUS RXi catheter following endovascular treatment for symptomatic lower extremity peripheral arterial disease.
Secondary objectives:
- Evaluation of correlation of the ABI and TBI and TLPGs at baseline and following endovascular therapy
- Evaluation of the correlation between the change in WIQ, TCOMs, wound size and change in TLPGS
- Evaluation of correlation between lesion severity by QVA (MLD, % diameter stenosis) and TLPGs
- Evaluation of baseline MLA, MLD, plaque burden by intravascular ultrasound (optional) and TLPGs
详细描述
There are a lack of tools available for the intraprocedural assessment of endovascular procedures for lower extremity peripheral arterial disease. The present study will use the NAVVUS RXi catheter to document changes in translesional hemodynamics obtained with and without hyperemia in patients undergoing directional atherectomy, angioplasty, and/or stenting of femoropopliteal and infrapoplieal lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Measurement of Change in translesional pressure gradients to determine change in bloodflow with sequential endovascular procedures
时间窗: At baseline before catheter insertion, after the catheter is first inserted, to obtain initial blood flow reading, then immediately after the each attempt to clear the blockage, up to 5 times during the procedure.
Observational: • During treatment of Lesion a catheter is inserted into the diseased portion of the artery to remove the plaque and improve the blood flow through the artery. This measurement, which may be repeated 5 times during the treatment, to measure the blood flow at a point before and after the section of the artery with the blockage
次要结局
未报告次要终点