Actively Recruiting
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
Led by VasoStar, LLC · Updated on 2025-09-16
10
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
V
VasoStar, LLC
Lead Sponsor
S
Summa Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the VasoStar Vibrational Guidewire System in patients with chronic total occlusion of the coronary artery and chronic angina who have lesions resistant to standard guidewire crossing. This early feasibility study aims to assess the initial safety and effectiveness of this device in crossing difficult coronary vascular lesions in non-tortuous arterial segments. The study focuses on patients with chronic angina refractory to maximally tolerated guideline-directed medical therapy. The VasoStar guidewire system is a device that vibrates longitudinally at the distal segment of a wire using an electromagnetic source to help cross vascular occlusion lesions. This system will be used during non-emergent coronary angioplasty procedures for chronic total occlusion lesions that have not been crossed by traditional guidewires. The trial involves a single treatment arm where the VasoStar guidewire system is applied to facilitate lesion crossing. Participants will be evaluated for successful crossing of the target lesion within one day and monitored for serious adverse events over 30 days. Longer-term assessments include improvements in 6-minute walk distance and Seattle Angina Questionnaire scores at 6 and 12 months after a successful procedure. Researchers will also track hospitalizations and emergency room visits for cardiac symptoms up to one year post-procedure. The study duration includes these follow-up periods to assess safety and effectiveness outcomes.
CONDITIONS
Brief Title
VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female over 18 years of age
- Presence of at least one ischemia-inducing lesion in a native coronary artery resistant to standard guidewire crossing
- Chronic total occlusion defined as 100% blockage for over 3 months documented by catheterization or clinical evaluation
- Suitable candidate for non-emergent coronary angioplasty
- Documented de-novo or restenotic coronary chronic total occlusion with TIMI 0 flow for at least 90 days
- Left ventricle ejection fraction greater than 20% within the last 12 months
- Activated clotting time over 300 seconds for antegrade procedures
- Chronic total occlusion in a non-tortuous arterial segment
- Voluntary signing of informed consent
- Physically and mentally willing to comply with study requirements
You will not qualify if you...
- Successful lesion crossing with conventional wire prior to enrollment
- Prisoners
- Pregnancy
- Presence of active implantable device
- Extensive dissection created by refractory guidewire
- Severe congestive heart failure (NYHA Class IV symptoms)
- Active infection
- Uncontrolled hypertension with systolic blood pressure over 180 mmHg at procedure time
- History of severe reaction to contrast media
- Recent myocardial infarction within 2 weeks
- In-stent target lesion
- Severe cerebrovascular disease or stroke/transient ischemic attack within 1 month
- Saphenous vein graft or 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 procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the procedure using the VasoStar guidewire system to cross vascular occlusion lesions.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and efficacy outcomes including walking distance, angina symptoms, and hospital visits following the procedure.
Visits at 30 days, 6 months, and 12 months (in-person or remote)
Trial Site Locations
Total: 2 locations
1
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
Summa Health
Akron, Ohio, United States, 44034
Actively Recruiting
Research Team
M
Mihaela Plesa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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