Wave Crossover ECP Study for Simplified Therapy

NCT06571370 | Completed Results FDA Device

• 1 other identifier: RA-C01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stable Angina; Refractory Angina

Keywords

external counterpulsation; ECP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Systolic Unloading (Mean)

  At last compression after 10 minutes of compression

• Systolic Unloading (Categorical)

  At last compression after 10 minutes of compression

Study Arms (2)

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

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

Device: External Counterpulsation

Interventions

External Counterpulsation DEVICE

Cardiac gated, lower limb compression

Predicate ECP Device, then Pression Wave PRO ECP System; Pression Wave PRO ECP System, then Predicate ECP Device

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pression: lead

Study Sites (1)

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

Location

MeSH Terms

Conditions

Angina, Stable; Angina Pectoris

Interventions

Counterpulsation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Assisted Circulation; Surgical Procedures, Operative

Results Point of Contact

• Title: Adam Salamon, Study Director
• Organization: Pression, Inc.

info@pression.com

215-326-9525

Study Officials

• Adam Salamon

  Pression, Inc. (Sponsor)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor is blinded to the participant but not the treatment device.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 26, 2024
• Study Start: September 26, 2024
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: March 9, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)