Wave Crossover ECP Study for Simplified Therapy

NCT06571370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-04-07

Study results available
· View outcomes & findings →

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

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571370 on ClinicalTrials.gov