Chronic Stable Angina, Refractory Angina
Conditions
Keywords
external counterpulsation, ECP
Brief summary
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.
Detailed description
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.
Interventions
Cardiac gated, lower limb compression
Sponsors
Pression
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor is blinded to the participant but not the treatment device.
Intervention model description
The proposed Study will be a randomized crossover study consisting of 52 participants (up to 100). Each participant will receive ECP compressions from the Wave PRO device and from the predicate (ACS NCP-2) ECP device, with the sequence of device use randomized to control bias.
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Augmentation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Unloading (Mean) | At last compression after 10 minutes of compression | The level of systolic unloading was recorded based on the systolic peaks during compressions compared to baseline PPG data. Systolic unloading is the percent change of peak systolic amplitude calculated as the difference of the compression waveform - non-compressed baseline waveform divided by amplitude at compression waveform. Systolic unloading components were measured using the peak systolic amplitude on the last compression waveform from the ECP session. The baseline non-compressed peak systolic amplitude was measured from the waveform immediately following the compressed waveform. Higher levels of systolic unloading are considered better. The predicate devices are documented to produce mean systolic unloading of approximately 11%. |
| Systolic Unloading (Categorical) | At last compression after 10 minutes of compression | Systolic unloading is the ratio of the systolic peak during compressions divided by baseline systolic peak. Systolic unloading is represented by a percentage decrease of systolic peak value with and without compression. This value should be \< 1. The baseline systolic peaks after compressions will be used. Higher levels of systolic unloading are considered better. The predicate devices are documented to produce mean systolic unloading of approximately 11%. |
Countries
United States
Contacts
STUDY_DIRECTORAdam Salamon
Pression, Inc. (Sponsor)
Participant flow
Recruitment details
60 subjects screened - 8 screen fails = 52 subjects randomized
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 60.9 Years STANDARD_DEVIATION 9.2 |
| Body Mass Index (BMI | 33.7 kg/m^2 STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type Type II (Fair skin; red or blond hair; blue, hazel, or green eyes) | 6 Participants |
| Fitzpatrick Skin Type Type III (Darker white; any eye or hair color) | 7 Participants |
| Fitzpatrick Skin Type Type I (Pale white skin; red or blond hair; blue/green eyes; freckles) | 3 Participants |
| Fitzpatrick Skin Type Type IV (Light brown skin) | 4 Participants |
| Fitzpatrick Skin Type Type V (Brown skin) | 17 Participants |
| Fitzpatrick Skin Type Type VI (Dark brown or black skin) | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 | 0 / 26 |
Outcome results
None listed