Wave Crossover ECP Study for Simplified Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Diastolic Augmentation
研究概览
简要总结
The purpose of this study is to demonstrate substantial equivalence between Pression's Wave PRO System and a commercially available predicate ECP device to support a U.S. 510(k) submission for the Wave PRO System.
详细描述
Participants will receive compressions from both ECP systems in a crossover design. Diastolic augmentation ratio and levels of systolic unloading will be evaluated for each participant on each test ECP system.
Participants will be aged 35+, with a history of coronary artery disease, serve as their own control, and meet the Inclusion Criteria and none of the Exclusion Criteria.
Test order of the ECP systems will be randomized for each participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor is blinded to the participant but not the treatment device.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 35 years or greater
- •History of mild to moderate coronary artery disease (CAD)
- •Able to ambulate without assistance
- •Able to lay down (approximately 5 degree angle) for the duration of study procedures
- •Able and willing to give informed consent
- •Able and willing to attend the ECP session and complete all questionnaires provided
排除标准
- •Unstable angina within prior 3 months
- •Canadian Cardiovascular Society (CCS) Class III or IV Angina
- •Moderate to severe peripheral arterial disease (PAD)
- •Myocardial infarction in the past 3 months
- •Coronary artery bypass grafting (CABG) in the past 3 months
- •Any major surgery within the past 3 months
- •Decompensated heart failure
- •Cardiac catheterization or arterial femoral puncture in the past 2 weeks
- •Presence of mechanical circulatory support (MCS) device
- •Pacemaker or other implantable pulse generating device
- •Valve disease, including aortic insufficiency
- •Abdominal or thoracic aortic dissection or aortic/cerebral aneurysms requiring clinical intervention
- •Severe pulmonary disease
- •Bleeding diathesis
- •Active thrombophlebitis
- •Uncontrolled hypertension (greater than 180/110 mmHg)
- •Baseline heart rate greater than 120 beats per minute or below 40 beats per minute
- •Arrhythmia and/or abnormal heart rhythm
- •Major hand injuries or amputation that would interfere with fingertip PPG
- •Unhealed wounds/fractures below the waist or lower limb amputation , general lower body musculoskeletal injuries
- •Vascular stents (arterial/venous) or orthopedic implants in the lower limbs
- •Currently undergoing ECP treatment
- •Pregnancy
- •Currently participating in any other clinical study of an investigational device or drug where treatment has not yet been completed
- •Participants with coagulopathy (PT-INR>2.5) or taking blood thinners (e.g., warfarin)
- •Any medical condition that, in the opinion of the principal investigator (PI), would present undue risk to the participant
研究组 & 干预措施
Pression Wave PRO ECP System, then Predicate ECP Device
Participant receives 10 minutes of compressions first with Pression Wave PRO ECP System, then the Predicate ECP Device
干预措施: External Counterpulsation (Device)
Predicate ECP Device, then Pression Wave PRO ECP System
Participant receives 10 minutes of compressions first with Predicate ECP Device, then compression with the Pression Wave PRO ECP System
干预措施: External Counterpulsation (Device)
结局指标
主要结局
Diastolic Augmentation
时间窗: During treatment, measured at the 8th minute of compressions
The primary effectiveness endpoint was the average Diastolic Augmentation (DA) ratio for the 8th minute of compressions with each ECP device tested for each participant, as identified by the blinded Independent Waveform Evaluator. Diastolic Augmentation (DA) ratio, also referred to as Diastolic/Systolic (D/S) ratio and Effectiveness Ratio (ER), noninvasively characterizes the hemodynamic effect and thus the clinical effectiveness of ECP treatment. DA ratio is a unitless measure which is "calculated as the ratio of the peak diastolic amplitude divided by the peak systolic amplitude" \[Suresh et al., 1998\]. In a typical, non-augmented, cardiac cycle, the diastolic peak is seen as a small increase in the arterial waveform just after the aortic valve closes (dicrotic notch). With augmentation, the peak diastolic amplitude is distinctly elevated and may reach a significant proportion of the peak systolic amplitude or in some cases exceed it.
次要结局
- Systolic Unloading (Mean)(At last compression after 10 minutes of compression)
- Systolic Unloading (Categorical)(At last compression after 10 minutes of compression)