Feasibility of 2D Perfusion DSA With Custom-made, Color-coded Software for the Quantification of Foot Perfusion Following Infrapopliteal Angioplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Perfusion Blood Flow (PBF)
研究概览
简要总结
A custom-made, 2D-perfusion digital subtraction angiography (PDSA) algorithm has been designed and implemented towards foot perfusion quantification following endovascular treatment of critical limb ischemia (CLI), in order to assist intra-procedural decision-making and enhance clinical outcomes.
详细描述
This is a prospective, single-center, study investigating the feasibility of 2D-PDSA using newly-developed, non-commercially available, color-coded software for the quantification of foot perfusion following infrapopliteal angioplasty for the treatment of CLI. In total, 7 consecutive patients scheduled to undergo infrapopliteal endovascular treatment of CLI were enrolled. Perfusion Blood Volume (PBV), Mean Transit Time (MTT), and Perfusion Blood Flow (PBF) maps were extracted by analyzing Time-Intensity Curves and signal intensity on the perfused vessel mask. Mean values calculated from user-specified ROIs on perfusion maps were employed to evaluate the patient's pre- and post- endovascular treatment condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
2D-perfusion imaging and analysis of the DICOM files was performed after revascularization, by an investigator blinded to the name of the patient or the result of the angioplasty procedure. The participant was also blinded to the results of the perfusion outcomes during follow up.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients prescheduled for infrapopliteal angioplasty due to chronic limb-threatening ischemia.
- •Written informed consent obtained
排除标准
- •Image post-processing not feasible due to significant motion artifacts produced during DSA
研究组 & 干预措施
Perfusion
Consecutive patients scheduled to undergo infrapopliteal angioplasty or stenting, or both, as part of their standard treatment for Rutherford-Becker class 5 and 6 chronic limb-threatening ischemia, were included in the study. All procedures were performed using local anesthesia. An antegrade access was used in all patients followed by the deployment of a 5 or 6 Fr arterial sheaths. A semi-lateral foot projection was preferred and the pre-revascularization DSA of the foot was performed via a 5 Fr angiographic catheter placed at the distal third of the popliteal artery. Following revascularization of one or more tibial arteries, the catheter was placed at the same popliteal segment and post-procedural DSA of the foot was performed following the exact pre-revascularization injection protocol at the same semi-lateral projection. The 2D-perfusion imaging and analysis of the DICOM files was performed after revascularization.
干预措施: 2D perfusion digital subtraction angiography of the foot. (Diagnostic Test)
结局指标
主要结局
Change in Perfusion Blood Flow (PBF)
时间窗: Ten minutes before and five minutes after the intervention
PBF calculated on subtraction images and pre- and post-procedural values compared using the proposed 2D perfusion DSA software.
Change in Perfusion Blood Volume (PBV)
时间窗: Ten minutes before and five minutes after the intervention
PBV calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software.
Change in Mean Transit Time (MTT)
时间窗: Ten minutes before and five minutes after the intervention
MTT calculated on subtraction images and pre- and post-procedural values were compared using the proposed 2D perfusion DSA software.
次要结局
- Procedure-related complications(30 days)
- Major amputation rate(Six months)
研究者
Stavros Spiliopoulos
Assistant Professor in Interventional Radiology
National and Kapodistrian University of Athens