Investigation of the Ringer Perfusion Balloon Catheter

NCT04849169 | Completed DMC FDA Device

• 1 other identifier: ST3031
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 6

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.

Conditions

Coronary Artery Perforation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in TIMI (thrombolysis in myocardial infarction) flow

  Procedure

• Change in perforation classification

  Procedure

• Rate of clinically relevant events

  Discharge or 30 days, whichever comes first.

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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

Interventions

Experimental DEVICE

Prolonged balloon inflation for hemorrhage management due to coronary artery perforation.

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The perforation location prevents complete inflation or proper placement of the Ringer catheter, as detailed in the Instructions for Use (IFU).

Sponsors & Collaborators

• Vascular Solutions LLC: lead

Study Sites (6)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory Heart & Vascular Center

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Washington Medical Center

Seattle, Washington, 98196, United States

Location

Study Officials

• David E Kandzari, MD

  Piedmont Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: July 18, 2022
• Primary Completion: November 21, 2023
• Study Completion: November 21, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)