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Completed

NCT Number: NCT06571370

Wave Crossover ECP Study for Simplified Therapy

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.

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Key information

Conditions

Chronic Stable Angina Angina Pectoris Angina, Stable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Refractory Angina Signs and Symptoms Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External Counterpulsation

Device

Cardiac gated, lower limb compression

Primary outcomes

  1. Diastolic Augmentation

    Time frame: During treatment, measured at the 8th minute of compressions

    The primary effectiveness endpoint was the average Diastolic Augmentation (DA) ratio for the 8th minute of compressions with each ECP device tested for each participant, as identified by the blinded Independent Waveform Evaluator. Diastolic Augmentation (DA) ratio, also referred to as Diastolic/Systolic (D/S) ratio and Effectiveness Ratio (ER), noninvasively characterizes the hemodynamic effect and thus the clinical effectiveness of ECP treatment. DA ratio is a unitless measure which is "calculated as the ratio of the peak diastolic amplitude divided by the peak systolic amplitude" [Suresh et al., 1998]. In a typical, non-augmented, cardiac cycle, the diastolic peak is seen as a small increase in the arterial waveform just after the aortic valve closes (dicrotic notch). With augmentation, the peak diastolic amplitude is distinctly elevated and may reach a significant proportion of the peak systolic amplitude or in some cases exceed it.

Secondary outcomes

  1. Systolic Unloading (Mean)

    Time frame: At last compression after 10 minutes of compression

    The level of systolic unloading was recorded based on the systolic peaks during compressions compared to baseline PPG data. Systolic unloading is the percent change of peak systolic amplitude calculated as the difference of the compression waveform - non-compressed baseline waveform divided by amplitude at compression waveform. Systolic unloading components were measured using the peak systolic amplitude on the last compression waveform from the ECP session. The baseline non-compressed peak systolic amplitude was measured from the waveform immediately following the compressed waveform. Higher levels of systolic unloading are considered better. The predicate devices are documented to produce mean systolic unloading of approximately 11%.

  2. Systolic Unloading (Categorical)

    Time frame: At last compression after 10 minutes of compression

    Systolic unloading is the ratio of the systolic peak during compressions divided by baseline systolic peak. Systolic unloading is represented by a percentage decrease of systolic peak value with and without compression. This value should be < 1. The baseline systolic peaks after compressions will be used. Higher levels of systolic unloading are considered better. The predicate devices are documented to produce mean systolic unloading of approximately 11%.

Sponsors and collaborators

Lead sponsor

Pression

Industry

Registry information

Acronym: WaveCRESST

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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