Status:
COMPLETED
LiquID Guide Catheter Extension Safety Study
Lead Sponsor:
Seigla Medical, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-89 years
Phase:
NA
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 C...
Eligibility Criteria
Inclusion
- 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 \<20%
- required intervention in a saphenous vein graft
- an intolerance or known allergy to medications/contrast expected to be used during the procedure or during hospital stay
- had a cardiac intervention within two weeks of the procedure
- renal insufficiency (serum creatinine of \> 2.3 mg/dl)
- active gastrointestinal bleeding
- an active infection or fever (\>37.8º C) that may be due to infection
- significant anemia (hemoglobin \< 8.0 mg / dl)
- severe uncontrolled systemic hypertension (systolic press. \> 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)
Exclusion
Key Trial Info
Start Date :
October 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2023
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05406596
Start Date
October 13 2022
End Date
October 20 2023
Last Update
May 23 2024
Active Locations (8)
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1
Ziekenhuis Oost-Limburg
Genk, Belgium
2
Mater Private
Cork, Ireland
3
Mater Private
Dublin, Ireland
4
Galway University Hospital
Galway, Ireland