BridgeMD
New treatment option for Chronic Total Occlusion of Coronary Artery
Official title VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions
ClinicalTrials.gov ID: NCT06193954
What this study is testing
- What it's testing
- The goal of this project is to provide an improvement in wire performance to expedite crossing difficult lesions in the coronary vasculature.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Left ventricle ejection fraction \> 20% within the last 12 months.
- For antegrade chronic total occlusion procedures, activated clotting time (ACT) should be \> 300 sec
You likely can't join if
- 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)
See the full eligibility 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%...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Akron, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Akron, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.