Investigation of the Ringer Perfusion Balloon Catheter

Study Overview
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Brief Summary
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The objective of this study is to demonstrate reasonable assurance that the Ringer catheter can be safely used to manage hemorrhage due to coronary vessel perforations while facilitating distal perfusion under the conditions of use prescribed in the labeling.

Detailed Description
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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.

Official Title
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A Prospective, Multicenter, Single-arm Investigation of the Ringer Perfusion Balloon Catheter Performed Under an Exception From Informed Consent (EFIC) (Ringer IDE Study)

Conditions
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Coronary Artery Perforation

Intervention / Treatment
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* Device: Experimental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: -The perforation location prevents complete inflation or proper placement of the Ringer catheter, as detailed in the Instructions for Use (IFU).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br>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. | Device: Experimental<br>* Prolonged balloon inflation for hemorrhage management due to coronary artery perforation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of device success in managing hemorrhage while preserving flow | 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. | Procedure | 
| Rate of Ringer related thrombosis and/or dissection | Rate of Ringer-related thrombosis and new or worsening coronary dissection following Ringer deflation and withdrawal. | Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TIMI (thrombolysis in myocardial infarction) flow | The change in TIMI flow during Ringer deployment. | Procedure | 
| Change in perforation classification | The change in perforation classification after Ringer deployment | Procedure | 
| Rate of clinically relevant events | 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. | Discharge or 30 days, whichever comes first. |