Health TrialsbyHealthPanel

VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions

ConditionsChronic Total Occlusion of Coronary ArteryChronic Angina
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • VasoStar guidewire system

    Device

    The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: VasoStar guidewire systemExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with successful crossing of the target lesion with the VasoStar guidewire system

Time frame
1 day
2

Incidence of Treatment-Emergent Serious Adverse Events

Number of device- or procedure- related serious adverse events

Time frame
30 days

Secondary outcomes

1

Improved 6-minute walk distance at 6 months following the VasoStar successful procedure

Time frame
6 months
2

Improved 6-minute walk distance at 12 months following the VasoStar successful procedure

Time frame
12 months
3

Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline

Time frame
6 months
4

Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VasoStar, LLC

Lead sponsor

Summa Health

Collaborator

Source ClinicalTrials.gov
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