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Vibrating wire aims to unclog hardened heart arteries

NCT ID NCT06193954

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early study tests a new vibrating guidewire designed to open completely blocked heart arteries (chronic total occlusions) in people with chronic chest pain that hasn't improved with standard treatments. The wire vibrates at its tip to help cross the blockage during a procedure. Ten participants will be enrolled to see if the wire can safely cross the blockage and improve symptoms like walking distance and chest pain over 6 to 12 months.

What this could mean

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

Active substance
VasoStar Vibrational Guidewire System (a device that vibrates to help cross blocked arteries)
What this could lead to
If it works, this device could offer a new way to open stubborn heart artery blockages, potentially reducing chest pain and improving walking ability.
What could go wrong
This is a very small early study with only 10 participants, so results may not apply to everyone. The device or procedure could cause serious side effects like artery damage or heart attack.

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 10 people

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

Started

Jun 2024

Expected to finish

Dec 2026

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.

Inclusion Criteria: * Male or female, over 18 years of age, presenting with at least one ischemia inducing lesion in a native coronary artery that is refractory to standard guidewire crossing. Chronic total occlusion (CTO) is defined as 100% coronary blockage for over a 3-month duration documented either by prior catheterization or by clinical evaluation * Suitable candidate for non-emergent, coronary angioplasty * Documented de-novo or restenotic coronary chronic total occlusion defined as a lesion with TIMI 0 flow for at least 90 days refractory to conventional guidewire crossing * Left ventricle ejection fraction \> 20% within the last 12 months. * For antegrade chronic total occlusion procedures, activated clotting time (ACT) should be \> 300 sec * Chronic total occlusion in a non-tortuous arterial segment * Voluntarily sign a Patient Informed Consent Form specific to the study. * Physically and mentally willing to comply with all study requirements. Exclusion Criteria: * Successful target lesion crossing with a conventional wire system prior to enrollment * Prisoners. * Pregnancy * Patient has an active implantable. * Extensive dissection created by refractory guidewire * Severe ongoing congestive heart failure (New York Heart Association Class IV symptoms) * Active infection * Uncontrolled Hypertension (Systolic blood pressure \> 180 mm) at the time of the procedure * History of severe reaction to contrast media * Recent myocardial infarction (within 2 weeks) * In-stent target lesion * Severe cerebrovascular disease including history of prior stroke or transient ischemic attack within 1 month at the time of the procedure * Saphenous vein graft (SVG) chronic total occlusion or an in-stent chronic total occlusion * Short life expectancy due to other illnesses such as cancer or pulmonary, hepatic or renal disease * Participation in another investigational protocol at the time of the procedure

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Summa Health

    RECRUITING

    Akron, Ohio, 44034, United States

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