Chronic Total Occlusion of Coronary ArteryVST100NCT06193954
VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
A study testing VasoStar guidewire system in people with Chronic Total Occlusion of Coronary Artery and Chronic Angina, run by VasoStar, LLC at 2 sites in United States.
Trial summary
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery, Chronic Angina
- What is being tested?
- VasoStar guidewire system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Summa Health
Akron, Ohio, 44034
Kevin Silver, MD
Kevin Silver, MD
- Recruiting
Emory University
Atlanta, Georgia, 30322
William Nicholson, MD
William Nicholson, MD
About this study
Official title: 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
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
Read the 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.
- Being tested
- VasoStar guidewire system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasoStar guidewire systemDevice
The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.
| Study group | Role | What they receive |
|---|---|---|
| VasoStar guidewire system | Experimental | The VasoStar guidewire system will be used to cross vascular occlusion lesions. Receives: Device: VasoStar guidewire system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with successful crossing of the target lesion with the VasoStar guidewire system
Measured: 1 day
Incidence of Treatment-Emergent Serious Adverse Events
Number of device- or procedure- related serious adverse events
Measured: 30 days
Secondary outcomes (6)
Improved 6-minute walk distance at 6 months following the VasoStar successful procedure
Measured: 6 months
Improved 6-minute walk distance at 12 months following the VasoStar successful procedure
Measured: 12 months
Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline
Measured: 6 months
Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline
Measured: 12 months
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants may be enrolled in the trial if an attempt to cross the target lesion with a standard wire fails.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VasoStar, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Summa Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193954
- Sponsor's protocol ID
- VST100
- Acronym
- VST100
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2023
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06193954
- Acronym / sponsor ID
- VST100 / VST100
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- VasoStar, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Summa Health
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants may be enrolled in the trial if an attempt to cross the target lesion with a standard wire fails.
| Arm | Type | Receives |
|---|---|---|
| VasoStar guidewire system | Experimental | Device: VasoStar guidewire systemThe VasoStar guidewire system will be used to cross vascular occlusion lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasoStar guidewire systemThe VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source. | Device | VasoStar guidewire system |
Primary outcome
Number of participants with successful crossing of the target lesion with the VasoStar guidewire system
Time frame: 1 day
Incidence of Treatment-Emergent Serious Adverse Events
Time frame: 30 days
Number of device- or procedure- related serious adverse events
6 secondary outcomes
Improved 6-minute walk distance at 6 months following the VasoStar successful procedure
Time frame: 6 months
Improved 6-minute walk distance at 12 months following the VasoStar successful procedure
Time frame: 12 months
Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline
Time frame: 6 months
Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline
Time frame: 12 months
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.
Time frame: 1 year
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.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VasoStar guidewire system in people with Chronic Total Occlusion of Coronary Artery and Chronic Angina, run by VasoStar, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mihaela Plesa (440 266 8226, fvtinfo@frantzgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with successful crossing of the target lesion with the VasoStar guidewire system (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.