Investigation of the Ringer Perfusion Balloon Catheter

Coronary Artery Perforation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04849169
• Other study ID #: ST3031
• Status: Completed
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: November 21, 2023

Study information

• Verified date: December 2023
• Source: Vascular Solutions LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Coronary Artery Perforation

Intervention

Device:
• Experimental
Prolonged balloon inflation for hemorrhage management due to coronary artery perforation.

Locations

Country	Name	City	State
United States	Emory Heart & Vascular Center	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Solutions LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in TIMI (thrombolysis in myocardial infarction) flow	The change in TIMI flow during Ringer deployment.	Procedure
Secondary	Change in perforation classification	The change in perforation classification after Ringer deployment	Procedure
Secondary	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.