Using a new guidewire system to treat blocked coronary arteries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the VasoStar guidewire system designed to improve the crossing of chronic total occlusions (CTOs) in coronary arteries. It aims to assess the initial safety and efficacy of this innovative device in patients with difficult-to-treat lesions that traditional guidewires cannot cross. Participants will undergo non-emergent coronary angioplasty, and the study will focus on those with documented CTOs lasting over three months. The goal is to enhance wire performance and expedite treatment for patients with chronic angina.

Why it matters

Who can join: the full rules

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

Where it's running

• Emory University
  Atlanta, Georgia, United States Recruiting
• Summa Health
  Akron, Ohio, United States Recruiting

Study contacts

• Study coordinator: Mihaela Plesa
• Email: fvtinfo@frantzgroup.com
• Phone: 440 266 8226

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing two approaches for treating blocked coronary arteries

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• Registry for treating chronic total occlusion of coronary arteries in Japan

  This study is gathering information from patients in Japan who have had a specific heart procedure to treat blocked arteries, to see how to improve treatment for these cases.

  Recruiting Kurashiki Central Hospital · Kurashiki · NCT01889459

• Plasma NT‑proBNP and the extent of coronary artery disease

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• Registry to track management and outcomes of patients with complex coronary artery disease

  This study is tracking how well different treatments for complex coronary artery disease work in patients who have had procedures like stents or bypass surgery.

  Recruiting Luzerner Kantonsspital · Lucerne, Canton of Lucerne · NCT06075602

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.