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

NCT06193954 | Recruiting DMC FDA Device

• 1 other identifier: VST100
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with successful crossing of the target lesion with the VasoStar guidewire system

  1 day

• Incidence of Treatment-Emergent Serious Adverse Events

  Number of device- or procedure- related serious adverse events

  30 days

Secondary Outcomes (6)

• Improved 6-minute walk distance at 6 months following the VasoStar successful procedure

  6 months

• Improved 6-minute walk distance at 12 months following the VasoStar successful procedure

  12 months

• Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline

  6 months

• Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline

  12 months

• Reduced number of hospitalizations for cardiac symptoms within 1 year following the VasoStar procedure, compared to the reported number of hospitalizations following standard CTO procedures.

  1 year

Study Arms (1)

VasoStar guidewire system

EXPERIMENTAL

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

Device: VasoStar guidewire system

Interventions

VasoStar guidewire system DEVICE

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

VasoStar guidewire system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VasoStar, LLC: lead
• Summa Health: collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Summa Health

Akron, Ohio, 44034, United States

RECRUITING

Central Study Contacts

Mihaela Plesa

CONTACT

440 266 8226; fvtinfo@frantzgroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants may be enrolled in the trial if an attempt to cross the target lesion with a standard wire fails.

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 5, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)