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LiquID Guide Catheter Extension Safety Study

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
LiquID GCE Use
Sponsored by
Seigla Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ziekenhuis Oost-LimburgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LiquID GCE Use

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
May 31, 2022
Last Updated
October 24, 2022
Sponsor
Seigla Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05406596
Brief Title
LiquID Guide Catheter Extension Safety Study
Official Title
LiquID Guide Catheter Extension Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seigla Medical, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LiquID GCE Use
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LiquID GCE Use
Intervention Description
Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
Primary Outcome Measure Information:
Title
In-hospital Major Adverse Cardiac Events (MACE)
Description
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)
Time Frame
48 hours or discharge (whichever comes first)
Secondary Outcome Measure Information:
Title
Device Oriented Clinical Outcome
Description
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.
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Schultz
Email
jschultz223@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Henriksen, BSc, MB ChB, PhD, FRCP
Organizational Affiliation
Royal Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Swijsen
Email
Caroline.Swijsen@zol.be

12. IPD Sharing Statement

Plan to Share IPD
No

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LiquID Guide Catheter Extension Safety Study

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