Investigation of the Ringer Perfusion Balloon Catheter
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|ClinicalTrials.gov Identifier: NCT04849169|
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : February 16, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Perforation||Device: Experimental||Not Applicable|
A prospective, multicenter, single-arm clinical study. The study will be conducted at up to 15 investigational sites in the US and will enroll up to 30 participants. The population for this investigation is adult participants who suffer a perforation of the coronary artery during a percutaneous coronary intervention requiring management of hemorrhage while providing distal perfusion until definite treatment is determined.
This clinical investigation is being conducted under Exception from Informed Consent (EFIC) regulations because there is no reasonable way to identify patients likely to become eligible for the investigation, and a coronary perforation can be a life-threatening emergency that needs to be immediately controlled without enough time for the patient or their legally authorized representative to give consent. Patients will be notified of their enrollment as soon as feasible. For more information on the exception from informed consent, please use the contact information be.ow.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter Performed Under an Exception From Informed Consent (EFIC) (Ringer IDE Study)|
|Actual Study Start Date :||July 18, 2022|
|Estimated Primary Completion Date :||February 28, 2024|
|Estimated Study Completion Date :||March 31, 2024|
Experimental: Experimental Arm
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.
Prolonged balloon inflation for hemorrhage management due to coronary artery perforation.
- Effectiveness of device success in managing hemorrhage while preserving flow [ Time Frame: Procedure ]Effectiveness of device success in managing hemorrhage while preserving flow via angiographic confirmation of: a) successful delivery of Ringer across perforation, b) acute cessation of extravasation while Ringer is inflated, and c) demonstration of antegrade blood flow during Ringer deployment.
- Rate of Ringer related thrombosis and/or dissection [ Time Frame: Procedure ]Rate of Ringer-related thrombosis and new or worsening coronary dissection following Ringer deflation and withdrawal.
- Change in TIMI (thrombolysis in myocardial infarction) flow [ Time Frame: Procedure ]The change in TIMI flow during Ringer deployment.
- Change in perforation classification [ Time Frame: Procedure ]The change in perforation classification after Ringer deployment
- Rate of clinically relevant events [ Time Frame: Discharge or 30 days, whichever comes first. ]Rate of clinically relevant events in the management of the coronary perforation and any potential sequelae including: chest pain, bleeding incidence and severity, major adverse cardiac events (MACE), cardiac tamponade and pericardiocentesis, emergency surgery post-perforation including coronary artery bypass graft (CABG), death.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- At least 18 years of age at the time of the PCI procedure
- Subject has fluoroscopically confirmed vessel perforation (classified as any type) requiring management of hemorrhage until a definitive treatment is determined
- Female subjects of childbearing potential must have a negative pregnancy test per standard of care for PCI
-The perforation location prevents complete inflation or proper placement of the Ringer catheter, as detailed in the Instructions for Use (IFU).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04849169
|Contact: Sherry Lanefirstname.lastname@example.org|
|Contact: Hannah Bearinger, PhDemail@example.com|
|United States, Georgia|
|Piedmont Heart Institute||Recruiting|
|Atlanta, Georgia, United States, 30309|
|Emory Heart & Vascular Center||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Massachusetts General Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|
|Brigham & Women's Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|Henry Ford Health System||Recruiting|
|Detroit, Michigan, United States, 48202|
|United States, Washington|
|University of Washington Medical Center||Recruiting|
|Seattle, Washington, United States, 98196|
|Contact: Kathleen Kearney, MD 206-388-9034 KaKearney@cardiology.washington.edu|
|Principal Investigator:||David E Kandzari, MD||Piedmont Heart Institute|
|Responsible Party:||Vascular Solutions LLC|
|Other Study ID Numbers:||
|First Posted:||April 19, 2021 Key Record Dates|
|Last Update Posted:||February 16, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|