Using a new guidewire system to treat blocked coronary arteries
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
This study is testing a new guidewire system to see if it can help doctors treat blocked coronary arteries in patients who have had these blockages for over three months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VasoStar, LLC Industry-sponsored |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06193954 on ClinicalTrials.gov |
What this trial studies
This study evaluates the VasoStar guidewire system designed to improve the crossing of chronic total occlusions (CTOs) in coronary arteries. It aims to assess the initial safety and efficacy of this innovative device in patients with difficult-to-treat lesions that traditional guidewires cannot cross. Participants will undergo non-emergent coronary angioplasty, and the study will focus on those with documented CTOs lasting over three months. The goal is to enhance wire performance and expedite treatment for patients with chronic angina.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic total occlusions in non-tortuous arterial segments that are resistant to standard guidewire crossing.
Not a fit: Patients with tortuous arterial segments or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with chronic total occlusions in coronary arteries.
How similar studies have performed: Other studies have explored innovative guidewire technologies, but the specific VasoStar system is a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia and 1 other locations
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Summa Health — Akron, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Mihaela Plesa
- Email: fvtinfo@frantzgroup.com
- Phone: 440 266 8226
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.