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New heart device shows promise for angina sufferers

NCT ID NCT06571370

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new device called the Wave PRO System that helps improve blood flow in people with chronic stable angina (chest pain). The device works by gently squeezing the legs to push more blood to the heart. The study included 52 adults with mild to moderate coronary artery disease. The goal was to see if the new device works as well as an existing device already on the market.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

52 people

The number who actually took part.

Started

Sep 2024

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Angina Pectoris Angina, Stable coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.