Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- ALI: Target Limb Salvage
研究概览
简要总结
This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the INDIGO System in Japan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
排除标准
- •Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
研究组 & 干预措施
Group 1: Indigo Aspiration System treatment
Mechanical aspiration thrombectomy
干预措施: Mechanical aspiration thrombectomy (Device)
结局指标
主要结局
ALI: Target Limb Salvage
时间窗: 30 days post-treatment and 6 months post-treatment
Target lower extremity salvage rate at (defined as: freedom from major amputation at or proximal to the ankle)
ALI: Technical Success
时间窗: Intraoperative
Primary technical success should be defined per vessel treated on an intent-to-treat basis and applies only to segment treated with Indigo. Defined as successful use of the device to re-establish any antegrade flow and complete or near complete (95% by volume) removal of thrombus as assessed by visual analysis of angiographic images or by other objective imaging such as DUS, CTA, or MRA.
All Disease States: Device-related Serious adverse effects (SAE) and mortality
时间窗: 6 months post-treatment
Device related SAE and all-cause mortality
SMA: Technical success
时间窗: Intraoperative
Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass.
DVT: Technical success
时间窗: Intraoperative
Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography
DVT: Major Device-Related Bleeding
时间窗: Periprocedural
Major device-related bleeding as defined by ISTH
ALI: Major device-related bleeding in ALI patients
时间窗: Periprocedural
Major bleeding events as defined by ISTH
SMA: Device-related Distal Embolization
时间窗: Intraoperative
A distal filling defect with an abrupt cut-off, determined to be new since the pre-procedure angiogram, present at the end of the procedure, and clinically significant requiring intervention other than Indigo use. If the area in question was not clearly visualized, filling defects distal to the target lesion cannot be categorized as emboli.
DVT: New Symptomatic Pulmonary Embolism (PE)
时间窗: 30 days post-treatment
Symptomatic new PE objectively confirmed on Computed Tomographic Pulmonary Angiography (CTPA), echocardiography, MRI, or invasive contrast pulmonary angiography.
DVT: Clinically significant re-thrombosis of the target venous segment
时间窗: 30 days post-treatment
Re-thrombosis of target vein segment requiring re-intervention within 30 days
次要结局
未报告次要终点