Chronic Angina, Chronic Total Occlusion of Coronary Artery
Conditions
Brief summary
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
Detailed 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.
Interventions
DEVICEVasoStar guidewire system
The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.
Sponsors
Summa Health
VasoStar, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants may be enrolled in the trial if an attempt to cross the target lesion with a standard wire fails.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 ventricle ejection fraction \> 20% within the last 12 months. * For antegrade chronic total occlusion procedures, activated clotting time (ACT) should be \> 300 sec * Chronic total occlusion in a non-tortuous arterial segment * Voluntarily sign a Patient Informed Consent Form specific to the study. * Physically and mentally willing to comply with all study requirements.
Exclusion criteria
* Successful target lesion crossing with a conventional wire system prior to enrollment * Prisoners. * Pregnancy * Patient has an active implantable. * Extensive dissection created by refractory guidewire * Severe ongoing congestive heart failure (New York Heart Association Class IV symptoms) * Active infection * Uncontrolled Hypertension (Systolic blood pressure \> 180 mm) at the time of the procedure * History of severe reaction to contrast media * Recent myocardial infarction (within 2 weeks) * In-stent target lesion * Severe cerebrovascular disease including history of prior stroke or transient ischemic attack within 1 month at the time of the procedure * Saphenous vein graft (SVG) chronic total occlusion or an in-stent chronic total occlusion * Short life expectancy due to other illnesses such as cancer or pulmonary, hepatic or renal disease * Participation in another investigational protocol at the time of the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with successful crossing of the target lesion with the VasoStar guidewire system | 1 day | — |
| Incidence of Treatment-Emergent Serious Adverse Events | 30 days | Number of device- or procedure- related serious adverse events |
Secondary
| Measure | Time frame |
|---|---|
| Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline | 6 months |
| Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline | 12 months |
| Improved 6-minute walk distance at 6 months following the VasoStar successful procedure | 6 months |
| 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. | 1 year |
| 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. | 1 year |
| Improved 6-minute walk distance at 12 months following the VasoStar successful procedure | 12 months |
Countries
United States
Contacts
Primary ContactMihaela Plesa
Outcome results
None listed