Wave Crossover ECP Study for Simplified Therapy
NCT06571370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2026-04-07
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
Interventions
- DEVICE
-
External Counterpulsation
Cardiac gated, lower limb compression
Sponsors & Collaborators
-
Pression
lead INDUSTRY
Principal Investigators
-
Adam Salamon · Pression, Inc. (Sponsor)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-26
- Primary Completion
- 2025-02-04
- Completion
- 2025-02-04
- FDA Device
- Yes
Countries
- United States
Study Locations
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