N/A
Completed N=86
LiquID Guide Catheter Extension Safety Study
Source: ClinicalTrials.gov NCT05406596 ↗Enrolled (actual)
86
Serious AEs
4.7%
Results posted
May 2024
Primary outcomePrimary: The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) — 2 Participants
Summary
Single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the LiquID Guide Catheter Extension
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) |
2 | — |
| SECONDARY The Number of Participants With Device Oriented Clinical Outcome |
79 | — |
Eligibility Criteria
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 2.3 mg/dl)
- active gastrointestinal bleeding
- an active infection or fever (>37.8º C) that may be due to infection
- significant anemia (hemoglobin 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)
Data sourced from ClinicalTrials.gov (NCT05406596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.