NCT06264843招募中不适用
Open, Prospective, Multicentre Study Addressing the Immediate Benefits and the Prognostic Value of Intraoperative Completion Control Following Infrainguinal Bypass Surgery in CLTI Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Medistim ASA
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Primary graft patency rate
研究概览
简要总结
The goal of the study is to identify and validate flow measurement and ultrasound images in patients undergoing vein bypass surgery below-knee and above ankle
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •CLTI as defined by presence of PAD in combination with rest pain, gangrene, or a lower limb ulceration>2 weeks duration (ref Global Guidelines)
- •Atherosclerotic infra-popliteal PAD
- •Adequate distal anastomotic target (crural, tibial or popliteal BTK with one single run-off) between knee and ankle distal to the stenotic/occluded segment.
- •Available autogenous vein conduit based on preoperative vein mapping.
- •Understand the nature of the procedure and willingness to comply with protocol. Attend follow-up appointments and provide written informed consent.
排除标准
- •Bypass with artificial conduit or cryopreserved allografts
- •Bypass for non-atherosclerotic lesions
- •Life-expectancy less than 2 years
- •Any psychological, developmental, physical or emotional disorder that the investigator believes would interfere with surgery or follow-up.
- •Any condition that the investigator believes should exclude participation.
- •Excessive risk for adverse events during open surgery as judged by the investigator.
研究组 & 干预措施
Patency of lower extremity vein bypass grafts
Primary patency of lower extremity vein bypass grafts at one year
干预措施: MiraQ with Transit-Time Flow Measurement (TTFM) and L15 High Frequency Ultrasound (HFUS) probes (Device)
结局指标
主要结局
Primary graft patency rate
时间窗: at 1 year
Freedom from any repeat graft intervention, graft thrombosis, or clinically significant stenosis (\>70% by either Duplex criteria or angiographic imaging) in the bypass
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Study of Methodologies to Measure Blood Flow and Oxygenation in Adults With Sickle Cell DiseaseHealthySickle Cell DiseaseNCT02447627Bioverativ Therapeutics Inc.38
进行中（未招募）
不适用
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval StudyIntracranial AneurysmNCT05409989Microvention-Terumo, Inc.154
撤回
不适用
Electrographic Flow Mapping Validation in Patients With Persistent Atrial Fibrillation (EVAL AF)Longstanding Persistent Atrial FibrillationPersistent Atrial FibrillationNCT05093868William Beaumont Hospitals
撤回
2 期
Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator FiringHeart FailureNCT01085175Lantheus Medical Imaging
已完成
不适用
Trauma Screening and SupplementationTraumaNutritional DeficiencyWound HealNCT03658278Michael C Willey400