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Sound wave device aims to crack hardened heart arteries

NCT ID NCT07510438

Disease control Sponsor: Amplitude Vascular Systems, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This first-in-human study tests a new device called Pulse IVL that uses sound waves to break up calcium buildup in heart arteries. Up to 15 people with coronary artery disease will receive the treatment before getting a stent. The goal is to see if the device is safe and helps open the artery enough for successful stenting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pulse Intravascular Lithotripsy (Pulse IVL) device
What this could lead to
If successful, this device could offer a safer way to prepare hardened arteries for stenting, potentially improving blood flow and reducing complications.
What could go wrong
This is a very early, small study with only 15 people. The device may not work as expected or could cause vessel damage. More research is needed before it becomes widely available.

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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

18 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.

Key Inclusion Criteria: * ≥ 18 years of age * Subjects with native coronary artery disease * Left ventricular ejection fraction (LVEF) ≥ 35% within 6 months * The target lesion must be a single de novo coronary lesion * The target lesion stenosis of left anterior descending artery (LAD), right coronary artery (RCA), left circumflex artery (LCX), or ramus intermedius (RI), or of their branches with Stenosis of ≥70% and \<100% or Stenosis ≥50% and \<70% with evidence of ischemia * Lesion length must not exceed 44 mm Key Exclusion Criteria: * Subject experienced an acute Myocardial Infarction (MI), either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days prior to index procedure. * Subject has New York Heart Association (NYHA) class III or IV heart failure. * Subject has renal failure with serum creatinine \>2.5 mg/dL, or chronic dialysis. * Subject has a previous stent in the target vessel implanted within last six months. * Unprotected LMCA diameter stenosis \>30%. * Target lesion has a myocardial bridge. * Target vessel is excessively tortuous, defined as the presence of 2 or more bends \>90 degrees or 3 or more bends \>75 degrees. * Evidence of aneurysm in target vessel within 10 mm of the target lesion. * Target lesion in ostial location (LAD, RCA, LCX, or RI, within 5 mm of ostium) or in an unprotected LMCA. * Target lesion is a bifurcation with ostial diameter stenosis ≥30%. * Any previous stent within 10 mm of the target lesion.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary arterial disease (CAD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Auckland City Hospital

    RECRUITING

    Auckland, 1142, New Zealand

  • Monash Health, Victorian Heart Hospital

    RECRUITING

    Melbourne, Victoria, 3168, Australia

  • St. Vincent's Hospital

    RECRUITING

    Sydney, New South Wales, 2010, Australia

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