At a glance
ClinicalIndex Comparison RecordN/ACompleted· 52 enrolled
Drug / intervention
External Counterpulsationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Wave Crossover ECP Study for Simplified Therapy
In Brief
A clinical study evaluating External Counterpulsation for Chronic Stable Angina and Refractory Angina. Completed, enrolled 52 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Stable Angina, Refractory Angina
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20252026
First PostedAug 2024
Enrollment StartSep 2024
Primary CompletionFeb 2025
TodayJul 2026
First PostedAug 26, 2024
Enrollment StartSep 26, 2024
Primary CompletionFeb 4, 2025
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 1.8 years ago
Interventions
External Counterpulsationdevice
Cardiac gated, lower limb compression