LiquID Guide Catheter Extension Safety Study

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: LiquID GCE Use

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LiquID GCE Use	Device: LiquID GCE Use; Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)	Device-caused events including:Target vessel dissectionLongitudinal stent deformationProximal 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Seigla Medical, Inc.
• Investigators: Principal Investigator: Peter Henriksen, BSc, MB ChB, PhD, FRCP, Royal Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): October 12, 2023
• Study Completion (Actual): October 20, 2023

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: June 3, 2022
• First Posted (Actual): June 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 23, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 200-0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes