LiquID Guide Catheter Extension Safety Study

Coronary Artery Disease Clinical Trial

Official title:

LiquID Guide Catheter Extension Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406596
• Other study ID #: 200-0004
• Status: Completed
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: October 20, 2023

Study information

• Verified date: April 2024
• Source: Seigla Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 20, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Ireland	Mater Private	Cork
Ireland	Mater Private	Dublin
Ireland	Galway University Hospital	Galway
United Kingdom	University Hospitals Bristol	Bristol
United Kingdom	Royal Edinburgh	Edinburgh
United Kingdom	Golden Jubilee	Glasgow
United Kingdom	St. George's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Seigla Medical, Inc.

Countries where clinical trial is conducted

Belgium,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)	Device-caused events including: Target vessel dissection; Longitudinal stent deformation; Proximal collar stent stripping; Cardiac death; Stroke; Peri-procedural myocardial infarction (MI) based on participant symptoms, ECG changes and/or SCAI definition (if cardiac enzymes are available)	48 hours or discharge (whichever comes first)
Secondary	The Number of Participants With Device Oriented Clinical Outcome	Successful deployment and retrieval of the LiquID device without any device deficiencies or where use of the LiquID device directly leads to a MACE, target vessel dissection, longitudinal stent deformation or proximal collar stent stripping.	1 Day