Wave Crossover ECP Study for Simplified Therapy (NCT06571370) | Clinical Trial Compass
CompletedNot Applicable
Wave Crossover ECP Study for Simplified Therapy
United States52 participantsStarted 2024-09-26
Plain-language 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.
Who can participate
Age range35 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 musculoskele…
What they're measuring
1
Diastolic Augmentation
Timeframe: During treatment, measured at the 8th minute of compressions