NCT06571370

Wave Crossover ECP Study for Simplified Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Pression · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Stable Angina
• Refractory Angina

Interventions

Type	Name	Description
DEVICE	External Counterpulsation	Cardiac gated, lower limb compression

Timeline

• Start date: 2024-09-26
• Primary completion: 2025-02-04
• Completion: 2025-02-04
• First posted: 2024-08-26
• Last updated: 2026-04-07
• Results posted: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study