Impedance Sensor Evaluated in Peripheral Artery Disease for Tissue Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal.
研究概览
简要总结
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD).
详细描述
The objective of the study is to evaluate the feasibility of the CSGS sensor to differentiate tissues involved in Peripheral Artery Disease (PAD)
Previously the CSGS was used in a clinical study in stroke patients (The Clot Out Study) to direct a catheter through blood vessels and to measure electrophysiological parameters in the blood vessels during procedures.
In the current study however, a commercially available CE marked guidewire will be used to direct a catheter through blood vessels while the Clotild® Smart Guidewire System will only be used to perform electrophysiological measurements in the blood vessels during peripheral endovascular procedures. It is thus designed for use as an adjunct to conventional angiographic procedures.
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
- •Age > 18 years
- •Subjects with acute and chronic occlusions in the arteries of the lower limbs
- •Patients eligible for endovascular interventional procedures
- •Written Informed Consent to participate in the study.
排除标准
- •Target Vessel Aneurysm
- •Target vessel diameter <2mm
- •Lesions starting at the Common Iliac Artery
- •Any subject that is, according to the discretion of the investigator, not eligible for study participation
- •Known lactating or confirmation of positive pregnancy test according to site specific standard of care
研究组 & 干预措施
Treatment Arm
One arm only - in all eligible study patients, the study device will be used.
干预措施: Clotild Smart Guidewire System (CSGS) (Device)
结局指标
主要结局
The Ability of Clotild® Smart Guidewire System (CSGS) to Acquire Electrophysiological Measurements in the Lesion and/or Subintimal.
时间窗: During the procedure, up to 95 minutes
The Primary Performance Endpoint is defined as the ability of Clotild® Smart Guidewire System to acquire electrophysiological measurements in the lesion and/or subintimal. This endpoint represents the procedural success rate being defined as the number of patients in whom the CSGS ( Clotild® Smart Guidewire System) obtained at least one non-anomalous impedance measurement in the lesion during the procedure, divided by the total number of patients in whom CSGS was used.
次要结局
- The Ability of Clotild® Smart Guidewire System to Differentiate Various Tissues Involved in Peripheral Artery Disease(During the procedure, up to 95 minutes)