Clinical trial NCT05406596: LiquID Guide Catheter Extension Safety Study
Official title: LiquID Guide Catheter Extension Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Seigla Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-06
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Cardiac Events (MACE) while performance measures will include Device Oriented Clinical Outcomes.

Eligibility 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)

Primary outcomes:
measure: The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)
timeFrame: 48 hours or discharge (whichever comes first)
Secondary outcomes:
measure: The Number of Participants With Device Oriented Clinical Outcome
timeFrame: 1 Day
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Cork
country: Ireland
facility: Mater Private
city: Dublin
country: Ireland
facility: Mater Private
city: Galway
country: Ireland
facility: Galway University Hospital
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol
city: Edinburgh
country: United Kingdom
facility: Royal Edinburgh
city: Glasgow
country: United Kingdom
facility: Golden Jubilee
city: London
country: United Kingdom
facility: St. George's Hospital
Study officials:
affiliation: Royal Edinburgh
name: Peter Henriksen, BSc, MB ChB, PhD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: