Aortix Therapy for Perioperative Reduction of Kidney Injury
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Number of Participants With Serious Adverse Events Related to Aortix
研究概览
简要总结
The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery.
详细描述
The study is a prospective, non-randomized feasibility study to evaluate the safety and performance of providing support with the Aortix System to patients at heightened risk of acute kidney injury (AKI) undergoing cardiovascular surgery. Patients who decline Aortix system implant or fail to meet anatomical requirements for Aortix implant will be followed in the non-Aortix arm. Both arms will have the same visit schedule and data collection requirements with the exception of data pertaining to the Aortix system. Data will be reported for both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the following risk factor(s) for AKI prior to surgery:
- •Estimated glomerular filtration rate (eGFR) of ≥ 15 and < 30 ml/min/1.73m2, OR
- •eGFR ≥ 30 and < 60 ml/min/1.73m2 and ONE or more of the following:
- •Diabetes (regardless of cause) with metabolic, renal, ophthalmic, neurologic, circulatory, or other complications
- •Documented NYHA class III or IV heart failure within 1 year prior to enrollment
- •Left ventricular ejection fraction < 35%
- •Hypertension with comorbid heart or kidney disease
- •Persistent Atrial Fibrillation
- •Planned (non-emergency) cardiac surgical procedure including, but not limited to coronary bypass surgery, surgical valve replacement or valve repair
- •Age >21 years, willing and able to provide written informed consent.
排除标准
- •An eGFR of <15 ml/min/1.73m2 at enrollment
- •Cardiac surgical procedure that uses femoral artery cannulation for cardiopulmonary bypass
- •Current support with a durable LVAD, intra-aortic balloon pump, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist devices (e.g., Impella or TandemHeart)
- •Patient has known hypo- or hyper-coagulable state such as disseminated intravascular coagulation or heparin induced thrombocytopenia (HIT)
- •Endovascular procedure with ilio-femoral access >12F within previous 30 days
- •Severe Bleeding Risk (any of the following):
- •Previous intracranial bleed such that the patient cannot safely use anticoagulation per the study requirements
- •Platelet count <75,000 cells/mm3
- •Uncorrectable bleeding diathesis or coagulopathy (e.g., INR ≥ 2 not due to anticoagulation therapy
- •Current endovascular stent graft in the descending aorta or either ilio-femoral vessels
- •Contraindicated Anatomy:
- •Descending aortic anatomy that would prevent safe placement of the device [<18 mm or >31 mm aorta diameter at deployment location (measured between the superior aspect of the T10 vertebra and superior aspect of the L1 vertebra)]
- •Ilio-femoral diameter or peripheral vascular anatomy that would preclude safe placement of a 21F (outer diameter) introducer sheath
- •Abnormalities or severe vascular disease that would preclude safe access and device delivery (e.g., aneurysm with thrombus; marked tortuosity; significant narrowing or inadequate size of the abdominal aorta, iliac, or femoral arteries; or severe calcification)
- •Known connective tissue disorder (e.g., Marfan Syndrome) or other aortopathy at risk of vascular injury
- •Known hypersensitivity or contraindication to study required medications (e.g., anticoagulation therapy) or device materials (e.g., history of severe reaction to nickel or nitinol)
- •Positive pregnancy test if of childbearing potential
- •Participation in any other clinical investigation that is likely to confound study results or affect the study
结局指标
主要结局
Number of Participants With Serious Adverse Events Related to Aortix
时间窗: Enrollment to 30 days post-surgery
The number of participants with Serious Adverse Events related to the Aortix implant, retrieval, and therapy.
Number of Participants With Baseline AKI Stage Compared to AKI Stage at 72 Hours Post-surgery
时间窗: Baseline to 72 hours post-surgery
The intention is to characterize the change in severity of acute kidney injury observed at 72 hours post-surgery using the KDIGO AKI staging criteria. AKI Stage as defined by the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guidelines defines the level of acute kidney injury with Stage 1 being the lowest level of kidney injury and Stage 3 being the most severe. None refers to no acute kidney injury.
Number of Participants Requiring Postoperative Use of Renal Replacement Therapy, Ultrafiltration, and/or Dialysis.
时间窗: Aortix placement to 30 days post- surgery
Renal replacement therapy (RRT), ultrafiltration, and dialysis are three treatment options for subjects with severe acute kidney injury and serve as a measure of the degree of acute kidney injury experienced by each group. Any subject receiving any of these therapies prior to 30 days post surgery are counted in this analysis.
Effectiveness
时间窗: If discharged by day 30 post-surgery
Characterize the rate of 30-day post-surgery readmission due to worsening renal function
次要结局
未报告次要终点