Recruiting

VasoStar

Sponsor:

VasoStar, LLC

Code:

NCT06193954

Conditions

Chronic Total Occlusion of Coronary Artery

Chronic Angina

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VasoStar guidewire system

Study Details

Brief summary:

The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.

Conditions

Chronic Total Occlusion of Coronary Artery

Chronic Angina

Study ID

NCT06193954

Start date

Jun 10, 2024

Status verified date

Sep, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VasoStar guidewire system

The VasoStar guidewire system will be used to cross vascular occlusion lesions.

Interventions

VasoStar guidewire system

The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.

Primary outcome measure

  • Number of participants with successful crossing of the target lesion with the VasoStar guidewire system [ Time Frame: 1 day ]
  • Incidence of Treatment-Emergent Serious Adverse Events [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Mihaela Plesa

440 266 8226fvtinfo@frantzgroup.com

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

William Nicholson, MD

Summa Health

Recruiting

Akron, Ohio, United States, 44034

Principal Investigator:

Kevin Silver, MD

More Information

Sponsor

VasoStar, LLC

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VasoStar, LLC on 2025-09-16.