NCT05406596

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
3 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 13, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2023

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
7 months until next milestone

Results Posted

Study results publicly available

May 8, 2024

Completed
Last Updated

May 23, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

May 31, 2022

Results QC Date

April 11, 2024

Last Update Submit

May 9, 2024

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Number of Participants With Device Oriented Clinical Outcome

    1 Day

Study Arms (1)

LiquID GCE Use

EXPERIMENTAL
Device: LiquID GCE Use

Interventions

LiquID GCE UseDEVICE

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

LiquID GCE Use

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

Mater Private

Cork, Ireland

Location

Mater Private

Dublin, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

University Hospitals Bristol

Bristol, United Kingdom

Location

Royal Edinburgh

Edinburgh, United Kingdom

Location

Golden Jubilee

Glasgow, United Kingdom

Location

St. George's Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
John Schultz
Organization
Seigla Medical
jschultz223@gmail.com
7632133026

Study Officials

  • Peter Henriksen, BSc, MB ChB, PhD, FRCP

    Royal Edinburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2022

First Posted

June 6, 2022

Study Start

October 13, 2022

Primary Completion

October 12, 2023

Study Completion

October 20, 2023

Last Updated

May 23, 2024

Results First Posted

May 8, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)IE(3)GB(4)