VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVasoStar, LLC
About this trial
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Successful target lesion crossing with a conventional wire system prior to enrollment
Prisoners.
Pregnancy
Patient has an active implantable.
Trial design
Treatments tested in this trial
- VasoStar guidewire system
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
VasoStar, LLC
Lead sponsor
Summa Health
Collaborator
Source ClinicalTrials.gov