LiquID Guide Catheter Extension Safety Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-13

Study Completion Date

2023-10-20

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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LiquID GCE Use

Group Type EXPERIMENTAL

LiquID GCE Use

Intervention Type DEVICE

Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)

Interventions

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LiquID GCE Use

Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No