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Wave Crossover ECP Study for Simplified Therapy

CompletedNot applicableNCT06571370
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Wave Crossover ECP Study for Simplified Therapy
Conditions
Interventions
  • Device: External Counterpulsation
Sponsor
Pression
Start date
2024-09-26
Primary completion
2025-02-04
Sex
All
Age range
from 35 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06571370