N/A
N=52
Wave Crossover ECP Study for Simplified Therapy
Chronic Stable Angina · Refractory Angina
Bottom Line
View on ClinicalTrials.gov: NCT06571370 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Diastolic Augmentation — 0.83; 0.57 Ratio — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- External Counterpulsation (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Pression
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diastolic Augmentation |
0.83; 0.57 | <0.0001 sig |
| SECONDARY Systolic Unloading (Mean) |
9.2 | — |
| SECONDARY Systolic Unloading (Categorical) |
27; 20 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 35 years or greater
- History of mild to moderate coronary artery disease (CAD)
- Able to ambulate without assistance
- Able to lay down (approximately 5 degree angle) for the duration of study procedures
- Able and willing to give informed consent
- Able and willing to attend the ECP session and complete all questionnaires provided
Exclusion Criteria
- Unstable angina within prior 3 months
- Canadian Cardiovascular Society (CCS) Class III or IV Angina
- Moderate to severe peripheral arterial disease (PAD)
- Myocardial infarction in the past 3 months
- Coronary artery bypass grafting (CABG) in the past 3 months
- Any major surgery within the past 3 months
- Decompensated heart failure
- Cardiac catheterization or arterial femoral puncture in the past 2 weeks
- Presence of mechanical circulatory support (MCS) device
- Pacemaker or other implantable pulse generating device
- Valve disease, including aortic insufficiency
- Abdominal or thoracic aortic dissection or aortic/cerebral aneurysms requiring clinical intervention
- Severe pulmonary disease
- Bleeding diathesis
- Active thrombophlebitis
- Uncontrolled hypertension (greater than 180/110 mmHg)
- Baseline heart rate greater than 120 beats per minute or below 40 beats per minute
- Arrhythmia and/or abnormal heart rhythm
- Major hand injuries or amputation that would interfere with fingertip PPG
- Unhealed wounds/fractures below the waist or lower limb amputation , general lower body musculoskeletal injuries
- Vascular stents (arterial/venous) or orthopedic implants in the lower limbs
- Currently undergoing ECP treatment
- Pregnancy
- Currently participating in any other clinical study of an investigational device or drug where treatment has not yet been completed
- Participants with coagulopathy (PT-INR>2.5) or taking blood thinners (e.g., warfarin)
- Any medical condition that, in the opinion of the principal investigator (PI), would present undue risk to the participant
Data sourced from ClinicalTrials.gov (NCT06571370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.