RECRUITING

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

Conditions

Chronic Total Occlusion of Coronary Artery Chronic Angina

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-06-10

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06193954

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Mihaela Plesa

CONTACT

440 266 8226

fvtinfo@frantzgroup.com

Study Locations (Sites)

Emory University

Atlanta, Georgia, 30322

United States

Summa Health

Akron, Ohio, 44034

United States

Collaborators and Investigators

Sponsor: VasoStar, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-10

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2024-06-10

Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

Chronic Total Occlusion of Coronary Artery
Chronic Angina