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VasoStar Guidewire System for Chronic Total Occlusions

This study is testing a new device called the VasoStar Vibrational Guidewire System. It's designed to help doctors cross very stubborn blockages in your heart arteries, called chronic total occlusions (CTO). These blockages are 100% blocked for over three months and haven't responded to standard wires. The study wants to see how well the VasoStar system works to get past these blockages and if it's safe. You might be able to join if you are over 18, have a CTO that's hard to cross with regular wires, and are a candidate for a non-emergency procedure. The study is currently unclear on its recruitment status.

Study design
This is an early study to evaluate the safety and effectiveness of the VasoStar guidewire system. It plans to enroll 10 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for successful crossing of the blockage at 1 day and serious side effects at 30 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06193954

VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions

Recruiting
NAAges 18+InterventionalTreatment
VasoStar, LLC
~10 participants
Updated 2025-09-16 on ClinicalTrials.gov
What's tested:VasoStar guidewire system

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with successful crossing of the target lesion with the VasoStar guidewire system
Measured over 1 day
+1 more outcome measured

Conditions

Chronic Total Occlusion of Coronary Artery
Chronic Angina

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AnginaChronic Total Coronary Artery Occlusion

Where it's being run

2 sites across 2 states
Georgia1
Ohio1

Who to contact

Mihaela Plesa
[email protected]
440 266 8226
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with successful crossing of the target lesion with the VasoStar guidewire system1 day
  • Incidence of Treatment-Emergent Serious Adverse Events30 days

    Number of device- or procedure- related serious adverse events