Wave Crossover ECP Study for Simplified Therapy (WaveCRESST)

March 18, 2026 updated by: Pression
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: External Counterpulsation
Cardiac gated, lower limb compression
Experimental: 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
Device: External Counterpulsation
Cardiac gated, lower limb compression

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During treatment, measured at the 8th minute of compressions

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Systolic Unloading (Mean)
Time Frame: 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%.
At last compression after 10 minutes of compression
Systolic Unloading (Categorical)
Time Frame: 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%.
At last compression after 10 minutes of compression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pression

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Adam Salamon, Pression, Inc. (Sponsor)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 26, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RA-C01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

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