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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pression Wave PRO ECP System, then Predicate ECP Device | Experimental | Participant receives 10 minutes of compressions first with Pression Wave PRO ECP System, then the Predicate ECP Device |
|
| Predicate ECP Device, then Pression Wave PRO ECP System | Experimental | Participant receives 10 minutes of compressions first with Predicate ECP Device, then compression with the Pression Wave PRO ECP System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External Counterpulsation | Device | Cardiac gated, lower limb compression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Augmentation | 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. | During treatment, measured at the 8th minute of compressions |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Unloading (Mean) | 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%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Salamon | Pression, Inc. (Sponsor) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
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60 subjects screened - 8 screen fails = 52 subjects randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Pression Wave PRO ECP System, Then Predicate ECP Device | Participant receives 10 minutes of compressions first with Pression Wave PRO ECP System, then with Predicate ECP Device |
| FG001 | Predicate ECP Device, Then Pression Wave PRO ECP System | Participant receives 10 minutes of compressions first with Predicate ECP Device, then with Pression Wave PRO ECP System |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First ECP Round (Day 0) |
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| Second ECP Round (Day 0) |
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| Evaluable Data Determination |
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Modified ITT population (N=51), excluding one subject for whom PPG signal could not be obtained.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pression Wave PRO ECP System, Then Predicate ECP Device | Participant receives 10 minutes of compressions first with Pression Wave PRO ECP System, then with Predicate ECP Device |
| BG001 | Predicate ECP Device, Then Pression Wave PRO ECP System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diastolic Augmentation | 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. | Modified ITT population of subjects who completed ECP compressions with both devices, Pression Wave PRO and Predicate (active comparator) | Posted | Least Squares Mean | 95% Confidence Interval | Ratio | During treatment, measured at the 8th minute of compressions | Waveforms | Waveforms |
From baseline to 24-hour telephone follow-up (window +1 to +3 days)
All adverse events were to be reported regardless of relatedness. All subjects underwent compressions with both the test and predicate ECP device. The sequence of devices was randomized. Due to the short time duration of testing with each device, individual AEs would not have been assignable to a specific intervention unless the AE occurred during that particular intervention. Therefore, adverse event information is reported by study arm (Wave PRO first or predicate ECP first).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pression Wave PRO ECP System, Then Predicate ECP Device | Participant receives 10 minutes of compressions first with Pression Wave PRO ECP System, then with Predicate ECP Device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Salamon, Study Director | Pression, Inc. | 215-326-9525 | info@pression.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2024 | Jan 14, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D060050 | Angina, Stable |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D015908 | Counterpulsation |
| ID | Term |
|---|---|
| D001243 | Assisted Circulation |
| D013514 | Surgical Procedures, Operative |
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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.
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Outcomes assessor is blinded to the participant but not the treatment device.
| At last compression after 10 minutes of compression |
| Systolic Unloading (Categorical) | 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%. | At last compression after 10 minutes of compression |
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Participant receives 10 minutes of compressions first with Predicate ECP Device, then with Pression Wave PRO ECP System |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI | Mean | Standard Deviation | kg/m^2 |
|
| Fitzpatrick Skin Type | Fitzpatrick Skin Type is the most commonly used skin tone classification system; it classifies skin into 6 categories based on an assessment of pigment and sensitivity to the sun. Used in this study to ensure distribution of participants across skin pigmentation spectrum. Fitzpatrick Skin Types not used to determine better or worse outcomes. Descriptors below courtesy of MSD Manual (https://www.msdmanuals.com/professional/multimedia/table/fitzpatrick-skin-type-classification). | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Pression Wave PRO ECP System | 10-minutes of ECP compressions applied by Pression Wave PRO ECP System, the experimental device |
| OG001 | Predicate ECP Device | 10-minutes of ECP compressions applied by the Predicate ECP Device, the active comparator |
|
|
|
| Secondary | Systolic Unloading (Mean) | 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%. | Analyzed only for Pression Wave PRO ECP results. Due to the way that the predicate device records waveform data, Sponsor was unable to evaluate systolic unloading for the predicate ECP device. | Posted | Mean | Standard Deviation | Percent change of peak systolic pressure | At last compression after 10 minutes of compression |
|
|
|
| Secondary | Systolic Unloading (Categorical) | 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%. | Due to the way that the predicate device records waveform data, Sponsor was unable to evaluate systolic unloading for the predicate ECP device. | Posted | Count of Participants | Participants | At last compression after 10 minutes of compression |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Predicate ECP Device, Then Pression Wave PRO ECP System | Participant receives 10 minutes of compressions first with Predicate ECP Device, then with Pression Wave PRO ECP System | 0 | 26 | 0 | 26 | 0 | 26 |
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| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |