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N/A

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

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

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

Do I qualify?Apply below to find out

Find a Location

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

Ringer Perfusion Balloon Catheter (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04849169 — N/A

Coronary Artery Perforation Research Study Groups: Experimental Arm

Coronary Artery Perforation Clinical Trial 2023: Ringer Perfusion Balloon Catheter Highlights & Side Effects. Trial Name: NCT04849169 — N/A

Ringer Perfusion Balloon Catheter (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04849169 — N/A

Frequently Asked Questions

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

How many applicants are being accepted into the clinical trial at this time?

"This investigation needs 30 compliant participants, who fit the predetermined standards of inclusion. People from University of Washington Medical Center in Seattle and Emory Heart & Vascular Center in Boston are eligible to take part."

Answered by AI

How widespread is the implementation of this investigation?

"6 clinical trial sites are presently recruiting patients, based in metropolitan areas such as Seattle, Boston and Detroit. It is recommended that individuals select the nearest location to reduce the amount of necessary travel if they choose to partake."

Answered by AI

Is this empirical research open to recruitment?

"Affirmative. The clinical trial page posted on clinicaltrials.gov states that the study, which was initially published in July of 2022, is presently searching for participants. A total of 30 patients must be recruited from 6 distinct medical sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Investigation of the Ringer Perfusion Balloon Catheter

2022. "Investigation of the Ringer Perfusion Balloon Catheter". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04849169.