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

Launched by VASOSTAR, LLC · Dec 21, 2023

Keywords

ClinConnect Summary

The VasoStar Vibrational Guidewire System clinical trial is studying a new tool designed to help doctors more effectively treat patients with a specific heart condition called Chronic Total Occlusion (CTO). This condition occurs when a coronary artery is completely blocked for at least three months, which can lead to chest pain and other heart problems. The goal of the trial is to see if this new guidewire can make it easier for doctors to cross these difficult blockages during a procedure called coronary angioplasty, which is used to open up narrowed or blocked arteries.

To participate in the trial, individuals must be over 18 years old and have at least one blockage in their coronary artery that has not responded to standard treatment. They should also be healthy enough to undergo the procedure, meaning they have a heart function that is sufficient and no severe ongoing heart failure or active infections. Participants will be asked to sign a consent form and will need to follow the study's requirements. This trial is currently recruiting participants, and it offers a chance to explore an innovative approach to treating challenging heart conditions.

Gender

ALL

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