VasoStar Vibrational Guidewire System to Facilitate Cross... | NCT06193954

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

NCT06193954

Sponsor

VasoStar, LLC

Status

Recruiting

Last Update Posted

Sep 16, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Chronic Total Occlusion of Coronary Artery
Chronic Angina

Interventions

VasoStar guidewire system

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2024Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 21, 2023

First Submission Date that Met QC Criteria

Dec 21, 2023

First Posted Date

Jan 5, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2025

Last Update Posted Date

Sep 16, 2025Actual

Name	Class
Summa Health	UNKNOWN

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VasoStar guidewire system	Experimental	The VasoStar guidewire system will be used to cross vascular occlusion lesions.	Device: VasoStar guidewire system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VasoStar guidewire system	Device	The VasoStar Vibrational Guidewire System vibrates longitudinally at the distal segment of a wire with an electromagnetic source.	VasoStar guidewire system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with successful crossing of the target lesion with the VasoStar guidewire system		1 day
Incidence of Treatment-Emergent Serious Adverse Events	Number of device- or procedure- related serious adverse events	30 days

Secondary Outcomes

Measure	Description	Time Frame
Improved 6-minute walk distance at 6 months following the VasoStar successful procedure		6 months
Improved 6-minute walk distance at 12 months following the VasoStar successful procedure		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided