VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions

Chronic Total Occlusion of Coronary Artery Clinical Trial

— VST100  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06193954
• Other study ID #: VST100
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 13, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: VasoStar, LLC
• Contact: Mihaela Plesa
• Phone: 440 266 8226
• Email: fvtinfo[@]frantzgroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Angina
• Chronic Total Occlusion of Coronary Artery

Intervention

Device:
• VasoStar guidewire system
The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.

Locations

Country	Name	City	State
United States	Summa Health	Akron	Ohio
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
VasoStar, LLC	Summa Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with successful crossing of the target lesion with the VasoStar guidewire system		1 day
Primary	Incidence of Treatment-Emergent Serious Adverse Events	Number of device- or procedure- related serious adverse events	30 days
Secondary	Improved 6-minute walk distance at 6 months following the VasoStar successful procedure		6 months
Secondary	Improved 6-minute walk distance at 12 months following the VasoStar successful procedure		12 months
Secondary	Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline		6 months
Secondary	Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline		12 months
Secondary	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
Secondary	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