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VasoStar guidewire system for Chronic Total Occlusions (VST100 Trial)

N/A

Waitlist Available

Research Sponsored by VasoStar, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Suitable candidate for non-emergent, coronary angioplasty

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

VST100 Trial Summary

This trial aims to develop better wires to navigate through challenging blockages in the heart's blood vessels.

Who is the study for?

This trial is for adults over 18 with chronic angina or total blockage in a coronary artery that's lasted more than 3 months and hasn't been cleared by standard treatments. They must have a left ventricle ejection fraction over 20% and be able to follow the study rules. People can't join if they're pregnant, prisoners, have severe heart failure, recent heart attack, uncontrolled high blood pressure, bad reactions to contrast media, certain brain vessel diseases or are in another study.Check my eligibility

What is being tested?

The VasoStar guidewire system is being tested to see if it can better help clear out completely blocked arteries in the heart that haven't responded to usual treatment methods. The aim is to make it easier and quicker for doctors to get through these tough blockages during angioplasty procedures.See study design

What are the potential side effects?

While specific side effects of the VasoStar guidewire system aren't listed here, similar procedures may include risks like bleeding at the catheter site, infection, damage to the artery wall or surrounding tissues and potential allergic reactions to materials used.

VST100 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 and have a heart blockage that can't be fixed with standard treatment.

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I am a good candidate for a planned procedure to open narrowed arteries in my heart.

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I have a complete blockage in a straight part of my artery.

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I have a complete blockage in my heart's artery that has lasted more than 3 months.

VST100 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Treatment-Emergent Serious Adverse Events

Number of participants with successful crossing of the target lesion with the VasoStar guidewire system

VST100 Trial Design

1Treatment groups

Experimental Treatment

Group I: VasoStar guidewire systemExperimental Treatment1 Intervention

The VasoStar guidewire system will be used to cross vascular occlusion lesions.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VasoStar, LLCLead Sponsor

Summa HealthUNKNOWN

1 Previous Clinical Trials

37 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"According to the information available on clinicaltrials.gov, this particular study is not currently actively seeking participants. It was initially posted on March 1st, 2024 and last updated on December 21st, 2023. However, it's worth noting that there are currently other ongoing trials accepting patients—specifically, a total of thirteen trials—that may be of interest to potential candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06193954.