Clinical trial NCT04849169: Investigation of the Ringer Perfusion Balloon Catheter
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Perforation
Lead sponsor: Vascular Solutions LLC
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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).

Primary outcomes:
measure: Effectiveness of device success in managing hemorrhage while preserving flow
timeFrame: Procedure
measure: Rate of Ringer related thrombosis and/or dissection
timeFrame: Procedure
Secondary outcomes:
measure: Change in TIMI (thrombolysis in myocardial infarction) flow
timeFrame: Procedure
measure: Change in perforation classification
timeFrame: Procedure
measure: Rate of clinically relevant events
timeFrame: Discharge or 30 days, whichever comes first.
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Heart & Vascular Center
state: Georgia
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Piedmont Heart Institute
name: David E Kandzari, MD
role: PRINCIPAL_INVESTIGATOR
References: