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Balloon Catheter
Ringer Perfusion Balloon Catheter for Coronary Artery Stenosis
N/A
Waitlist Available
Led By Kathleen Kearney, MD
Research Sponsored by Vascular Solutions LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during procedure
Awards & highlights
Study Summary
This trial is testing whether a Ringer perfusion balloon catheter is safe and effective for dilating coronary stenoses during PCI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Coronary Stenosis
Rate of clinically relevant events
Secondary outcome measures
Ringer Inflation
Successful PCI
TIMI Flow
Trial Design
1Treatment groups
Experimental Treatment
Group I: ExperimentalExperimental Treatment1 Intervention
Adult subjects clinically indicated for non-emergent percutaneous coronary intervention (PCI) as a stand-alone procedure or following non-emergent diagnostic angiography performed during the same procedure that, in the physician's estimation, requires prolonged balloon inflation with distal perfusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ringer Perfusion Balloon Catheter
2022
N/A
~60
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Who is running the clinical trial?
Vascular Solutions LLCLead Sponsor
8 Previous Clinical Trials
722 Total Patients Enrolled
Ridardo DeMedeiros, PhDStudy DirectorTeleflex
Kathleen Kearney, MDPrincipal InvestigatorUniversity of Washington
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