Investigation of the Ringer Perfusion Balloon Catheter

Vascular Solutions

Status: Completed

Conditions: Coronary Artery Perforation

Treatments: Device: Experimental

Study type: Interventional

Funder types: Industry

Identifiers

NCT04849169

ST3031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Experimental Arm

Experimental group

Description:

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.

Treatment:

Device: Experimental