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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
Sponsor:
Information provided by (Responsible Party):
Vascular Solutions LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Perforation Device: Experimental Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
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.
 Device: Experimental
Prolonged balloon inflation for hemorrhage management due to coronary artery perforation.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change in TIMI (thrombolysis in myocardial infarction) flow [ Time Frame: Procedure ]
    The change in TIMI flow during Ringer deployment.

  2. Change in perforation classification [ Time Frame: Procedure ]
    The change in perforation classification after Ringer deployment

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Sherry Lane 612-499-3531 sherry.lane@teleflex.com
Contact: Hannah Bearinger, PhD 612-345-4544 hannah@brightresearchpartners.com

Locations
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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   
Sponsors and Collaborators
Vascular Solutions LLC
Investigators
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Principal Investigator: David E Kandzari, MD Piedmont Heart Institute
More Information
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Responsible Party: Vascular Solutions LLC
ClinicalTrials.gov Identifier: NCT04849169    
Other Study ID Numbers: ST3031
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

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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