Low Frequency Therapeutic Ultrasound System Pivotal Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 8
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
Multi-center randomized trial to assess the safety and performance of low-frequency therapeutic ultrasound for maintaining renal function after contrast exposure.
详细描述
This is a multi-center, randomized, controlled clinical trial designed to assess the safety and performance of the Sonogenix RENOBOOST as an adjunctive therapy for maintaining renal function after contrast exposure. The trial will enroll up to 234 subjects not taking oral nitrates and at high-risk of developing PC-AKI undergoing coronary arteriography for a planned percutaneous coronary intervention in up to 10 clinical sites in the US and up to 3 clinical sites outside the US.
All subjects will be pre- treated with 0.9 percent NaCl at 3 ml/kg/h 1 hour before and 1 ml/kg/h during and 6 hours post procedure. Participants will be randomized in a 2:1 fashion to either active adjunctive therapy with the Sonogenix RENOBOOST or sham control.
Subjects will have clinical follow-up examination 30 days post index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participant and clinical staff will be blinded to which arm the participant is randomized.
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
- •Participant is greater than or equal to 18 years
- •Baseline renal dysfunction defined as one of the following:
- •eGFR greater than 30
- •eGFR 30-45, with or without risk factors for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
- •eGFR 45-60, with at least one risk factor for AKI defined as diabetes mellitus, congestive heart failure, proteinuria (defined as albuminuria greater than 300mg/day).
- •Participant is presenting for a planned percutaneous coronary intervention (PCI)
- •Participant scheduled to undergo cardiac catheterization including coronary arteriography that is anticipated to require at least 100 ml of iso-osmolar or low- osmolar contrast, and that is anticipated to include single-vessel stent implantation that does not include chronic total occlusion.
- •Participant had not been hospitalized or treated for a change in renal function within 30 days of enrollment.
- •Participant has provided written informed consent.
- •Participant is willing to comply with study follow-up requirements.
排除标准
- •Participant is anuric or currently undergoing renal replacement therapy.
- •Participant is currently taking oral nitrates.
- •Participant is undergoing a procedure requiring selective cannulation and injection of contrast into the renal arteries.
- •Participant presented with ST-segment elevation myocardial infarction.
- •Participant has a metal implant in the hip or lumbar spine.
- •Participant received or is anticipated to receive additional intravenous or intraarterial contrast from 7 days prior to cardiac catheterization to 4 days after cardiac catheterization.
- •Addition, discontinuation, or dose change of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, diuretic, trimethoprim, non-steroidal anti-inflammatory drugs, cimetidine, or metoclopramide with 7 days prior to cardiac catheterization.
- •Participant has a known allergy to contrast medium that cannot be adequately pre-medicated.
- •Participant has new-onset heart failure with New York Heart Association (NYHA) classification of III or IV within 30 days prior to the index procedure.
- •Recent stroke within 90 days prior to the index procedure.
- •Participant has known or suspected active infection at the time of the index procedure.
- •Participant is pregnant and/or breast-feeding or intends to become pregnant during the time of the study.
- •Participant is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.
- •Participant is known to be incarcerated, mentally incompetent, and/or alcohol or drug abuser.
- •Participant is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or subject is planning to participate in such studies prior to the completion of this study.
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: 48 hours
Incidence of acute kidney injury (AKI) defined as a greater than 0.3 mg/dl increase in serum creatinine (SCr)
Primary Safety Endpoint
时间窗: 30 days
Composite of all Adverse Events (AE) including RENOBOOST (device) related adverse events, and major adverse events (MAE)
次要结局
- Incidence of Post Contrast Acute Kidney Injury(within 96 hours post-contrast exposure or need for RRT)
- Incidence of contrast-induced nephropathy(within 96 hours post-contrast exposure or need for RRT)
- Hospitalization(following the baseline procedure through discharge from the hospital up to 30 days)
- Occurrence of (stage 1, 2, or 3) acute kidney injury (AKI)(within 96 hours of index procedure)
- Maximum percent-change(within 96 hours after contrast exposure)
- Absolute and percent-change in estimated glomerular filtration rate (eGFR)(from baseline within 96 hours after contrast exposure.)
- Total urine output(through baseline procedure)
- Intensive Care(following the baseline procedure through discharge from the Intensive Care Unit up to 30 days)