Investigation of the Ringer Perfusion Balloon Catheter
- Conditions
- Coronary Artery Perforation
- Interventions
- Device: Experimental
- Registration Number
- NCT04849169
- Lead Sponsor
- Vascular Solutions LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
-The perforation location prevents complete inflation or proper placement of the Ringer catheter, as detailed in the Instructions for Use (IFU).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 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.
- Primary Outcome Measures
Name Time Method Rate of Ringer related thrombosis and/or dissection Procedure Rate of Ringer-related thrombosis and new or worsening coronary dissection following Ringer deflation and withdrawal.
Effectiveness of device success in managing hemorrhage while preserving flow 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.
- Secondary Outcome Measures
Name Time Method Change in TIMI (thrombolysis in myocardial infarction) flow Procedure The change in TIMI flow during Ringer deployment.
Change in perforation classification Procedure The change in perforation classification after Ringer deployment
Rate of clinically relevant events 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.
Trial Locations
- Locations (6)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Emory Heart & Vascular Center
🇺🇸Atlanta, Georgia, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States