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Ringer Catheter for Coronary Artery Perforation
N/A
Waitlist Available
Led By David E Kandzari, 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 procedure
Awards & highlights
Study Summary
This trial is to show that a Ringer catheter is a safe and effective way to manage bleeding from a coronary vessel perforation while still allowing blood flow to the rest of the body.
Who is the study for?
This trial is for adults over 18 with confirmed coronary vessel perforation needing hemorrhage control until a final treatment plan. Women who can have children must test negative for pregnancy. People can't join if the catheter cannot be fully inflated or properly placed due to the location of the perforation.Check my eligibility
What is being tested?
The study aims to ensure that the Ringer Perfusion Balloon Catheter is safe and effective in managing bleeding caused by coronary artery perforations while also maintaining blood flow beyond the site of injury.See study design
What are the potential side effects?
While specific side effects are not listed, potential risks may include complications related to catheter insertion, such as additional damage to vessels, infection risk, or reactions at the insertion site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effectiveness of device success in managing hemorrhage while preserving flow
Rate of Ringer related thrombosis and/or dissection
Secondary outcome measures
Change in TIMI (thrombolysis in myocardial infarction) flow
Change in perforation classification
Rate of clinically relevant events
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental ArmExperimental Treatment1 Intervention
Adult subjects who experience a perforation of a coronary vessel during percutaneous coronary intervention (PCI) and require management of hemorrhage until a definitive treatment is determined.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental
2008
Completed Phase 2
~2200
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Who is running the clinical trial?
Vascular Solutions LLCLead Sponsor
8 Previous Clinical Trials
752 Total Patients Enrolled
David E Kandzari, MDPrincipal InvestigatorPiedmont Heart Institute
5 Previous Clinical Trials
1,250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Experimental Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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