Vibrating wire aims to unclog hardened heart arteries
NCT ID NCT06193954
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
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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
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Emory University
RECRUITINGAtlanta, Georgia, 30322, United States
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Summa Health
RECRUITINGAkron, Ohio, 44034, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New Stent-Like device aims to adapt to heart arteries
- Can a vibrating wire reopen completely blocked heart arteries?
- Opening blocked heart arteries may beat drugs alone for reducing oxygen starvation
- Heart artery blockage showdown: which approach wins?
- Heart stent study reveals long-term narrowing risks after complex artery procedure
- Heart attack prevention: does opening a blocked artery save lives?