VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions (VST100)

Evaluation of a Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions in Patients With Chronic Angina Refractory to Maximally Tolerated Guideline Directed Medical Therapy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Total Occlusion of Coronary Artery; Chronic Angina
• Intervention / Treatment: Device: VasoStar guidewire system

Detailed Description

This Early Feasibility Study (EFS) is proposed to evaluate the initial safety and efficacy of the VasoStar guidewire system to cross complex coronary vascular lesions in non-tortuous arterial segments which are resistant to crossing with a traditional interventional guidewire.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mihaela Plesa; Phone Number: 440 266 8226; Email: mplesa@frantzgroup.com

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
      • Principal Investigator: William Nicholson, MD
      • Contact: William Nicholson, MD
  • Ohio
    • Akron, Ohio, United States, 44034
      • Summa Health
      • Contact: Kevin Silver, MD
      • Principal Investigator: Kevin Silver, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VasoStar guidewire system; The VasoStar guidewire system will be used to cross vascular occlusion lesions.	Device: VasoStar guidewire system; The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a 0.014" wire with an electromagnetic source to dissipate friction and probe an infinite number of points on the leading edge of the obstructive plaque.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with successful crossing of the target lesion with the VasoStar guidewire system	Number of participants in whom the VasoStar guidewire successfully positioned in the distal vessel true lumen after initial failure to cross the target lesion with appropriate commercial standard workhorse wires	1 day
Incidence of Treatment-Emergent Serious Adverse Events	Number of device- or procedure- related serious adverse events	30 days

Collaborators and Investigators

• Sponsor: VasoStar, LLC
• Collaborators: Summa Health

Study record dates

Study Major Dates

• Study Start (Estimated): May 13, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VST100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes