LiquID Guide Catheter Extension Safety Study

Study Overview
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Brief Summary
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Single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the LiquID Guide Catheter Extension

Detailed Description
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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.

Official Title
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LiquID Guide Catheter Extension Safety Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: LiquID GCE Use


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - participants must be: scheduled for non-emergent, percutaneous coronary procedure in which the use of a guide catheter extension is anticipated able to provide informed consent to participate in the study Exclusion Criteria - participants must not have: evidence of ongoing ST-elevation myocardial infarction (STEMI) or STEMI treatment for late presentation STEMI with index admission (stabilized acute coronary syndrome allowed) left ventricular ejection fraction <20% required intervention in a saphenous vein graft an intolerance or known allergy to medications/contrast expected to be used during the procedure or during hospital stay had a cardiac intervention within two weeks of the procedure renal insufficiency (serum creatinine of > 2.3 mg/dl) active gastrointestinal bleeding an active infection or fever (>37.8º C) that may be due to infection significant anemia (hemoglobin < 8.0 mg / dl) severe uncontrolled systemic hypertension (systolic press. > 240 mm Hg within the past month) a severe electrolyte imbalance congestive heart failure (NYHA Class IV) presented with an acute coronary syndrome where serum troponin concentrations have not been demonstrated to be declining prior to the scheduled procedure (within the past two weeks) uncontrolled diabetes (> 2 serum glucose concentrations of > 350 mg/dl within the past 7 days) participation in an investigational protocol unwillingness or inability to comply with any protocol requirements angina, or ischemia caused by occluded artery other clinical conditions, that in the opinion of the investigator significantly compromise the ability to perform a safe and/or effective procedure Vulnerable Population Exclusion - participants must not be: under 18 years old pregnant or nursing immuno-compromised over 89 years old incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consent (including emergency situations)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LiquID GCE Use<br> | Device: LiquID GCE Use<br>* Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 48 hours or discharge (whichever comes first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 Day |