NCT06571370Completed
Wave Crossover ECP Study for Simplified Therapy
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 22 Aug 2024
- Start date
- 26 Sept 2024
- Primary completion date
- 4 Feb 2025
- Lead sponsor
- Pression
- Diseases
- Coronary artery disease
- NCT number
- NCT06571370
What you commit to
- Study type: Interventional
- Participants enrolled: 52
- From 26 Sept 2024 to the primary completion date, 4 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unstable angina within prior 3 months
- Any major surgery within the past 3 months
- Vascular stents (arterial/venous) or orthopedic implants in the lower limbs
- Currently participating in any other clinical study of an investigational device or drug where treatment has not yet been completed
Other illness
- Canadian Cardiovascular Society (CCS) Class III or IV Angina
- Moderate to severe peripheral arterial disease (PAD)
- Myocardial infarction in the past 3 months
- Decompensated heart failure
- Cardiac catheterization or arterial femoral puncture in the past 2 weeks
- Valve disease, including aortic insufficiency
- Severe pulmonary disease
- Bleeding diathesis
- 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
- Any medical condition that, in the opinion of the principal investigator (PI), would present undue risk to the participant
Lab values
- Participants with coagulopathy (PT-INR\>2.5) or taking blood thinners (e.g., warfarin)
Other
- Coronary artery bypass grafting (CABG) in the past 3 months
- Presence of mechanical circulatory support (MCS) device
- Pacemaker or other implantable pulse generating device
- Abdominal or thoracic aortic dissection or aortic/cerebral aneurysms requiring clinical intervention
- Active thrombophlebitis
- 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
- Currently undergoing ECP treatment
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 35 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Monroe Biomedical Research Coordinator of this site? Confirm its status | Monroe | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.