Trials / Recruiting
RecruitingNCT06193954
VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- VasoStar, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VasoStar guidewire system | The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source. |
Timeline
- Start date
- 2024-06-10
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2024-01-05
- Last updated
- 2025-09-16
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06193954. Inclusion in this directory is not an endorsement.