Coronary Artery Disease
Conditions
Brief summary
Single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the LiquID Guide Catheter Extension
Detailed description
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.
Interventions
DEVICELiquID GCE Use
Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
Sponsors
Seigla Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
- participants must be: 1. scheduled for non-emergent, percutaneous coronary procedure in which the use of a guide catheter extension is anticipated 2. able to provide informed consent to participate in the study
Exclusion criteria
- participants must not have: 1. evidence of ongoing ST-elevation myocardial infarction (STEMI) or STEMI treatment for late presentation STEMI with index admission (stabilized acute coronary syndrome allowed) 2. left ventricular ejection fraction \<20% 3. required intervention in a saphenous vein graft 4. an intolerance or known allergy to medications/contrast expected to be used during the procedure or during hospital stay 5. had a cardiac intervention within two weeks of the procedure 6. renal insufficiency (serum creatinine of \> 2.3 mg/dl) 7. active gastrointestinal bleeding 8. an active infection or fever (\>37.8º C) that may be due to infection 9. significant anemia (hemoglobin \< 8.0 mg / dl) 10. severe uncontrolled systemic hypertension (systolic press. \> 240 mm Hg within the past month) 11. a severe electrolyte imbalance 12. congestive heart failure (NYHA Class IV) 13. 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) 14. uncontrolled diabetes (\> 2 serum glucose concentrations of \> 350 mg/dl within the past 7 days) 15. participation in an investigational protocol 16. unwillingness or inability to comply with any protocol requirements 17. angina, or ischemia caused by occluded artery 18. 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: 1. under 18 years old 2. pregnant or nursing 3. immuno-compromised 4. over 89 years old 5. incapacitated, mentally compromised or otherwise incapable of understanding and/or providing informed consent (including emergency situations)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | 48 hours or discharge (whichever comes first) | * 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Device Oriented Clinical Outcome | 1 Day | 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. |
Countries
Belgium, Ireland, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LiquID GCE Use LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI) | 86 |
| Total | 86 |
Baseline characteristics
| Characteristic | LiquID GCE Use | — |
|---|---|---|
| Age, Continuous | 68.1 years STANDARD_DEVIATION 10.1 | — |
| Diabetes | 20 Participants | — |
| History of Angiography (no PCI) | 46 Participants | — |
| History of CABG | 11 Participants | — |
| History of Cerebrovascular PTA | 1 Participants | — |
| History of PCI | 41 Participants | — |
| History of Peripheral PTA | 4 Participants | — |
| Hypercholesterolemia | 68 Participants | — |
| Hypertension | 57 Participants | — |
| Infectious Disease (HIV, TB, etc.) | 2 Participants | — |
| Medication Allergy | 13 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Belgium | 19 participants | — |
| Region of Enrollment Ireland | 31 participants | — |
| Region of Enrollment United Kingdom | 36 participants | — |
| Sex: Female, Male Female | 18 Participants | — |
| Sex: Female, Male Male | 68 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 86 |
| other Total, other adverse events | 15 / 86 |
| serious Total, serious adverse events | 4 / 86 |
Outcome results
Primary
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)
Population: All participants were analyzed for any adverse events that may have occurred.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LiquID GCE Use | The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) | 2 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LiquID GCE Use | The Number of Participants With Device Oriented Clinical Outcome | 79 Participants |