Wave Crossover ECP Study for Simplified Therapy (WaveCRESST)

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: Completed
• Conditions: Refractory Angina; Chronic Stable Angina
• Intervention / Treatment: Device: External Counterpulsation

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: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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%.	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

Collaborators and Investigators

• Sponsor: Pression
• Investigators: Study Director: Adam Salamon, Pression, Inc. (Sponsor)

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Actual): February 4, 2025
• Study Completion (Actual): February 4, 2025

Study Registration Dates

• First Submitted: August 22, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ECP; external counterpulsation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Chest Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Angina Pectoris; Angina, Stable; Surgical Procedures, Operative; Assisted Circulation; Counterpulsation
• Other Study ID 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