Wave Crossover ECP Study for Simplified Therapy (WaveCRESST)

Pression

Status: Completed

Conditions: Refractory Angina; Chronic Stable Angina

Treatments: Device: External Counterpulsation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06571370

RA-C01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Pression Wave PRO ECP System, then Predicate ECP Device

Experimental group

Description:

Participant receives 10 minutes of compressions first with Pression Wave PRO ECP System, then the Predicate ECP Device

Treatment:

Device: External Counterpulsation

Predicate ECP Device, then Pression Wave PRO ECP System

Experimental group

Description:

Participant receives 10 minutes of compressions first with Predicate ECP Device, then compression with the Pression Wave PRO ECP System

Treatment:

Device: External Counterpulsation