The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.
Emory University
Atlanta, Georgia, United States
RECRUITINGSumma Health
Akron, Ohio, United States
RECRUITINGNumber 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
Number of device- or procedure- related serious adverse events
Time frame: 30 days
Improved 6-minute walk distance at 6 months following the VasoStar successful procedure
Time frame: 6 months
Improved 6-minute walk distance at 12 months following the VasoStar successful procedure
Time frame: 12 months
Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline
Time frame: 6 months
Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline
Time frame: 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.
Time frame: 1 year
Reduced number of emergency room visits for cardiac symptoms within 1 year following the VasoStar procedure, compared to the reported number of hospitalizations following standard CTO procedures.
Time frame: 1 year
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