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
VasoStar, LLC
Summary
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 ven…
Interventions
- DeviceVasoStar guidewire system
The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.
Locations (2)
- Emory UniversityAtlanta, Georgia
- Summa HealthAkron, Ohio