Single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the LiquID Guide Catheter Extension
The study will consist of evaluating the safety and performance of the LiquID Guide Catheter Extension (GCE) compared to historical data. The safety measures will consist of procedural Major Adverse Cardiac Events (MACE) while performance measures will include Device Oriented Clinical Outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
Ziekenhuis Oost-Limburg
Genk, Belgium
Mater Private
Cork, Ireland
Mater Private
Dublin, Ireland
Galway University Hospital
Galway, Ireland
The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
* Device-caused events including: * Target vessel dissection * Longitudinal stent deformation * Proximal collar stent stripping * Cardiac death * Stroke * Peri-procedural myocardial infarction (MI) based on participant symptoms, ECG changes and/or SCAI definition (if cardiac enzymes are available)
Time frame: 48 hours or discharge (whichever comes first)
The Number of Participants With Device Oriented Clinical Outcome
Successful deployment and retrieval of the LiquID device without any device deficiencies or where use of the LiquID device directly leads to a MACE, target vessel dissection, longitudinal stent deformation or proximal collar stent stripping.
Time frame: 1 Day
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University Hospitals Bristol
Bristol, United Kingdom
Royal Edinburgh
Edinburgh, United Kingdom
Golden Jubilee
Glasgow, United Kingdom
St. George's Hospital
London, United Kingdom