VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- VasoStar, LLC
- Study ID
- NCT06193954
- Status
- Recruiting
Conditions
- Chronic Angina
- Chronic Total Occlusion of Coronary Artery
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- VasoStar guidewire system — DEVICEThe VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.
Study Details
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
Key Dates
- Start date
- Jun 10, 2024
- Status verified
- Sep 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: VasoStar guidewire systemThe VasoStar guidewire system will be used to cross vascular occlusion lesions.
Primary Outcome Measure
Number of participants with successful crossing of the target lesion with the VasoStar guidewire system [ Time Frame: 1 day ]
Central Contacts
- Mihaela Plesa440 266 8226
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | William Nicholson, MD William Nicholson, MD (PRINCIPAL_INVESTIGATOR) |
| Summa Health | Akron | Ohio | 44034 | Kevin Silver, MD Kevin Silver, MD (PRINCIPAL_INVESTIGATOR) |
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