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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.
Age
35 - No limit years
Sex
ALL
Healthy Volunteers
No
Monroe Biomedical Research
Monroe, North Carolina, United States
Start Date
September 26, 2024
Primary Completion Date
February 4, 2025
Completion Date
February 4, 2025
Last Updated
March 9, 2026
52
ACTUAL participants
External Counterpulsation
DEVICE
Lead Sponsor
Pression
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04915157