VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlus… (NCT06193954) | Clinical Trial Compass
RecruitingNot Applicable
VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
United States10 participantsStarted 2024-06-10
Plain-language summary
The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-st…
What they're measuring
1
Number of participants with successful crossing of the target lesion with the VasoStar guidewire system
Timeframe: 1 day
2
Incidence of Treatment-Emergent Serious Adverse Events