Wave Crossover ECP Study for Simplified Therapy

Completed · Not applicable

Conditions studied: Chronic Stable Angina, Refractory Angina

In brief

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.

Key facts

Study ID

NCT06571370

Run by

Pression

People needed

52

Starts

2024-09-26

Expected to finish

2025-02-04

Last updated by the study team

2026-04-07

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Monroe Biomedical Research — Monroe, North Carolina, United States

Full record on ClinicalTrials.gov

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