Coronary Artery DiseaseNCT05406596
LiquID Guide Catheter Extension Safety Study
A study testing LiquID GCE Use in people with Coronary Artery Disease, run by Seigla Medical, Inc. at 8 sites in 3 countries.
Trial summary
Single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the LiquID Guide Catheter Extension Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- LiquID GCE Use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 13 Oct 2022to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 24Show fewer
- 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)
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United Kingdom4 sites
University Hospitals Bristol
Bristol
Royal Edinburgh
Edinburgh
Golden Jubilee
Glasgow
St. George's Hospital
London
Ireland3 sites
Mater Private
Cork
Mater Private
Dublin
Galway University Hospital
Galway
About this study
Single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the LiquID Guide Catheter Extension
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- LiquID GCE Use
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquID GCE UseDevice
Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
| Study group | Role | What they receive |
|---|---|---|
| LiquID GCE Use | Experimental | Not described Receives: Device: LiquID GCE Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 48 hours or discharge (whichever comes first)
Secondary outcomes (1)
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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start13 Oct 2022
- Primary completion12 Oct 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seigla Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Henriksen, BSc, MB ChB, PhD, FRCP, Principal investigator, Royal Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406596
- Sponsor's protocol ID
- 200-0004
- Status last verified
- Apr 2024
- First submitted
- 31 May 2022
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LiquID Guide Catheter Extension Safety Study
- ClinicalTrials.gov ID
- NCT05406596
- Acronym / sponsor ID
- 200-0004
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Seigla Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Posted 8 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LiquID GCE Use | Experimental | Device: LiquID GCE Use |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiquID GCE UseUse of the LiquID GCE to aid in percutaneous coronary intervention (PCI) | Device | LiquID GCE Use |
Primary outcome
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)
1 secondary outcome
The Number of Participants With Device Oriented Clinical Outcome
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Henriksen, BSc, MB ChB, PhD, FRCP principal investigator
Royal Edinburgh
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiquID GCE Use in people with Coronary Artery Disease, run by Seigla Medical, Inc. at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Ireland, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) (time frame: 48 hours or discharge (whichever comes first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.