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Completed

NCT Number: NCT05406596

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg, Genk, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LiquID GCE Use

Device

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

Primary outcomes

  1. The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)

    Time frame: 48 hours or discharge (whichever comes first)

    • 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)

Secondary outcomes

  1. The Number of Participants With Device Oriented Clinical Outcome

    Time frame: 1 Day

    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.

Sponsors and collaborators

Lead sponsor

Seigla Medical, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2022
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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