Chronic Stable AnginaWaveCRESSTNCT06571370
Wave Crossover ECP Study for Simplified Therapy
A study testing External Counterpulsation in people with Chronic Stable Angina and Refractory Angina, run by Pression at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Stable Angina, Refractory Angina
- What is being tested?
- External Counterpulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to 4 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe Biomedical Research
Monroe, North Carolina, 28112
About this study
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.
Read the 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.
- Conditions
- Chronic Stable Angina, Refractory Angina
- Being tested
- External Counterpulsation
- Keywords
- external counterpulsation, ECP
- Medical subject headings
- Angina, Stable, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External CounterpulsationDevice
Cardiac gated, lower limb compression
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: External Counterpulsation |
| 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 Receives: Device: External Counterpulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During treatment, measured at the 8th minute of compressions
Secondary outcomes (2)
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%.
Measured: 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%.
Measured: At last compression after 10 minutes of compression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start26 Sep 2024
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pression
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Salamon, Study director, Pression, Inc. (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571370
- Sponsor's protocol ID
- RA-C01
- Acronym
- WaveCRESST
- Status last verified
- Mar 2026
- First submitted
- 22 Aug 2024
- Last updated
- 7 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wave Crossover ECP Study for Simplified Therapy
- ClinicalTrials.gov ID
- NCT06571370
- Acronym / sponsor ID
- WaveCRESST / RA-C01
- Conditions
- Chronic Stable Angina, Refractory Angina
- Keywords
- external counterpulsation, ECP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- PressionIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 26 Aug 2024 (actual)
- Results
- Posted 9 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pression Wave PRO ECP System, then Predicate ECP Device | Experimental | Device: External CounterpulsationParticipant 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 | Device: External CounterpulsationParticipant receives 10 minutes of compressions first with Predicate ECP Device, then compression with the Pression Wave PRO ECP System |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External CounterpulsationCardiac gated, lower limb compression | Device | Predicate ECP Device, then Pression Wave PRO ECP System, Pression Wave PRO ECP System, then Predicate ECP Device |
Primary outcome
Diastolic Augmentation
Time frame: 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.
2 secondary outcomes
Systolic Unloading (Mean)
Time frame: At last compression after 10 minutes of compression
Systolic Unloading (Categorical)
Time frame: At last compression after 10 minutes of compression
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Chronic Stable Angina
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
RecruitingObservational study
Identification of Lesion Characteristics in Coronary Plaques Using Multimodality Intravascular Imaging and Novel Photon-counting CT in Stable Angina
Coronary Artery Disease (CAD), Stable Angina Pectoris
RecruitingObservational study
Barts Revascularisation Registry
Myocardial Infarction, Stable Angina
Not yet recruitingObservational study
Clinical Evidence With Biomarker Confirmation for PPMI in PCI Clinical Trials Study
Peri-procedural Myocardial Infarction, Heart Failure Hospitalization
Active, not recruiting
SELUTION 4 De Novo Small Vessel IDE Trial
Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Salamon study director
Pression, Inc. (Sponsor)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Counterpulsation in people with Chronic Stable Angina and Refractory Angina, run by Pression at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diastolic Augmentation (time frame: During treatment, measured at the 8th minute of compressions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.