Trial Outcomes & Findings for LiquID Guide Catheter Extension Safety Study (NCT NCT05406596)

Last Updated: 2024-05-23

Results Overview

* 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)

Recruitment status

COMPLETED

Study phase

Target enrollment

86 participants

Primary outcome timeframe

48 hours or discharge (whichever comes first)

Results posted on

2024-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	LiquID GCE Use LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
Overall Study STARTED	86
Overall Study COMPLETED	86
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LiquID GCE Use n=86 Participants LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
Age, Continuous	68.1 years STANDARD_DEVIATION 10.1 • n=86 Participants
Sex: Female, Male Female	18 Participants n=86 Participants
Sex: Female, Male Male	68 Participants n=86 Participants
Region of Enrollment United Kingdom	36 participants n=86 Participants
Region of Enrollment Belgium	19 participants n=86 Participants
Region of Enrollment Ireland	31 participants n=86 Participants
Diabetes	20 Participants n=86 Participants
Hypertension	57 Participants n=86 Participants
Hypercholesterolemia	68 Participants n=86 Participants
Medication Allergy	13 Participants n=86 Participants
Infectious Disease (HIV, TB, etc.)	2 Participants n=86 Participants
History of CABG	11 Participants n=86 Participants
History of PCI	41 Participants n=86 Participants
History of Angiography (no PCI)	46 Participants n=86 Participants
History of Peripheral PTA	4 Participants n=86 Participants
History of Cerebrovascular PTA	1 Participants n=86 Participants

PRIMARY outcome

Timeframe: 48 hours or discharge (whichever comes first)

Population: All participants were analyzed for any adverse events that may have occurred.

Outcome measures

Outcome measures
Measure	LiquID GCE Use n=86 Participants LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	LiquID GCE Use n=86 Participants LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
The Number of Participants With Device Oriented Clinical Outcome	79 Participants

Adverse Events

LiquID GCE Use

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LiquID GCE Use n=86 participants at risk LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
Vascular disorders Dissection	1.2% 1/86 • Number of events 1 • 10 days
Vascular disorders Dissection/MI	1.2% 1/86 • Number of events 1 • 10 days
Cardiac disorders Chest Pain	1.2% 1/86 • Number of events 1 • 10 days
General disorders Palpitations, dizziness	1.2% 1/86 • Number of events 1 • 10 days

Other adverse events

Other adverse events
Measure	LiquID GCE Use n=86 participants at risk LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI)
Respiratory, thoracic and mediastinal disorders Shortness of Breath	2.3% 2/86 • Number of events 2 • 10 days
Injury, poisoning and procedural complications Arm Wound	1.2% 1/86 • Number of events 1 • 10 days
Blood and lymphatic system disorders Hypokalemia	1.2% 1/86 • Number of events 1 • 10 days
Infections and infestations COVID-19	3.5% 3/86 • Number of events 3 • 10 days
Injury, poisoning and procedural complications Chest Pain	1.2% 1/86 • Number of events 1 • 10 days
General disorders Chest Pain	3.5% 3/86 • Number of events 3 • 10 days
Vascular disorders Left Foot Swelling	1.2% 1/86 • Number of events 1 • 10 days
Cardiac disorders Transient Ischemic Attack	1.2% 1/86 • Number of events 1 • 10 days
Blood and lymphatic system disorders Orthostatic hypotension	1.2% 1/86 • Number of events 1 • 10 days
Musculoskeletal and connective tissue disorders Left Arm Cramping	1.2% 1/86 • Number of events 1 • 10 days

Additional Information

John Schultz

Seigla Medical

Phone: 7632133026

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place