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Single arm, open label, historically controlled, multicenter study evaluating the primary safety and performance of the LiquID Guide Catheter Extension
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LiquID GCE Use | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LiquID GCE Use | Device | Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) |
| 48 hours or discharge (whichever comes first) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 Day |
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Inclusion Criteria - participants must be:
Exclusion Criteria - participants must not have:
Vulnerable Population Exclusion - participants must not be:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Henriksen, BSc, MB ChB, PhD, FRCP | Royal Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Belgium | ||||
| Mater Private |
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| ID | Title | Description |
|---|---|---|
| FG000 | LiquID GCE Use | LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who were successfully screened
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| ID | Title | Description |
|---|---|---|
| BG000 | LiquID GCE Use | LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE) |
| All participants were analyzed for any adverse events that may have occurred. | Posted | Count of Participants | Participants | 48 hours or discharge (whichever comes first) |
|
10 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LiquID GCE Use | LiquID GCE Use: Use of the LiquID GCE to aid in percutaneous coronary intervention (PCI) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dissection | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Schultz | Seigla Medical | 7632133026 | jschultz223@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2022 | Apr 11, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Cork |
| Ireland |
| Mater Private | Dublin | Ireland |
| Galway University Hospital | Galway | Ireland |
| University Hospitals Bristol | Bristol | United Kingdom |
| Royal Edinburgh | Edinburgh | United Kingdom |
| Golden Jubilee | Glasgow | United Kingdom |
| St. George's Hospital | London | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Hypercholesterolemia | Count of Participants | Participants |
|
| Medication Allergy | Count of Participants | Participants |
|
| Infectious Disease (HIV, TB, etc.) | Count of Participants | Participants |
|
| History of CABG | Count of Participants | Participants |
|
| History of PCI | Count of Participants | Participants |
|
| History of Angiography (no PCI) | Count of Participants | Participants |
|
| History of Peripheral PTA | Count of Participants | Participants |
|
| History of Cerebrovascular PTA | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 Day |
|
|
|
| 0 |
| 86 |
| 4 |
| 86 |
| 15 |
| 86 |
| Dissection/MI | Vascular disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Palpitations, dizziness | General disorders | Systematic Assessment |
|
| Arm Wound | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypokalemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Chest Pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Chest Pain | General disorders | Systematic Assessment |
|
| Left Foot Swelling | Vascular disorders | Systematic Assessment |
|
| Transient Ischemic Attack | Cardiac disorders | Systematic Assessment |
|
| Orthostatic hypotension | Blood and lymphatic system disorders | Systematic Assessment |
|
| Left Arm Cramping | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |