Actively Recruiting
VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
Led by VasoStar, LLC · Updated on 2025-09-16
10
Participants Needed
2
Research Sites
133 weeks
Total Duration
On this page
Sponsors
V
VasoStar, LLC
Lead Sponsor
S
Summa Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
CONDITIONS
Official 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
- At least one ischemia-inducing lesion in a native coronary artery refractory to standard guidewire crossing
- Documented chronic total occlusion of 100% blockage for over 3 months
- Suitable candidate for non-emergent coronary angioplasty
- Chronic total occlusion with TIMI 0 flow for at least 90 days refractory to conventional guidewire crossing
- Left ventricle ejection fraction greater than 20% within the last 12 months
- Activated clotting time greater than 300 seconds for antegrade procedures
- Chronic total occlusion in a non-tortuous arterial segment
- Willing and able to sign informed consent
- Physically and mentally able to comply with study requirements
You will not qualify if you...
- Successful target lesion crossing with a conventional wire before enrollment
- Prisoners
- Pregnancy
- Active implantable device
- Extensive dissection caused by previous guidewire
- Severe congestive heart failure (NYHA Class IV symptoms)
- Active infection
- Uncontrolled hypertension with systolic blood pressure over 180 mm at procedure time
- History of severe reaction to contrast media
- Recent myocardial infarction within 2 weeks
- In-stent target lesion
- Severe cerebrovascular disease including stroke or TIA within 1 month
- Saphenous vein graft or in-stent chronic total occlusion
- Short life expectancy due to other serious illnesses
- 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
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
CONTACT
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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