LiquID Guide Catheter Extension Safety Study

Seigla Medical

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: LiquID GCE Use

Study type: Interventional

Funder types: Industry

Identifiers

NCT05406596

200-0004

Details and patient eligibility

About

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

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

LiquID GCE Use

Experimental group

Treatment:

Device: LiquID GCE Use