N/A N=86 Treatment

LiquID Guide Catheter Extension Safety Study

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT05406596 ↗

Enrolled (actual)

Serious AEs

4.7%

Results posted

May 2024

Primary outcome: Primary: The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) — 2 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LiquID GCE Use (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Seigla Medical, Inc.
Primary completion: Oct 2023

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	—

Summary

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

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)

View full record on ClinicalTrials.gov →

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.