Clinical trial NCT06193954: VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Total Occlusion of Coronary Artery
Chronic Angina
Lead sponsor: VasoStar, LLC
Sponsor class: INDUSTRY
Collaborators: name: Summa Health
First posted: 2024-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants may be enrolled in the trial if an attempt to cross the target lesion with a standard wire fails.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants with successful crossing of the target lesion with the VasoStar guidewire system
timeFrame: 1 day
measure: Incidence of Treatment-Emergent Serious Adverse Events
timeFrame: 30 days
Secondary outcomes:
measure: Improved 6-minute walk distance at 6 months following the VasoStar successful procedure
timeFrame: 6 months
measure: Improved 6-minute walk distance at 12 months following the VasoStar successful procedure
timeFrame: 12 months
measure: Improved score on the Seattle Angina Questionnaire at the 6-month visit compared to the score at baseline
timeFrame: 6 months
measure: Improved score on the Seattle Angina Questionnaire at the 12-month visit compared to the score at baseline
timeFrame: 12 months
measure: 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.
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Akron
country: United States
facility: Summa Health
state: Ohio
Study officials:
References: