LiquID Guide Catheter Extension Safety Study

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: LiquID GCE Use

• Registration Number: NCT05406596
• Lead Sponsor: Seigla Medical, Inc.

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.

Study Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-06-03
• Study First Posted: 2022-06-06
• Study Start: 2022-10-13
• Primary Completion: 2023-10-12
• Study Completion: 2023-10-20
• Status Verified: 2024-04
• Results First Submitted: 2024-04-11
• Results First Submitted QC: 2024-04-11
• Results First Posted: 2024-05-08
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LiquID GCE Use	LiquID GCE Use	-

Primary Outcome Measures

Name	Time	Method
The Number of Participants With In-hospital Major Adverse Cardiac Events (MACE)	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)

Secondary Outcome Measures

Name	Time	Method
The Number of Participants With Device Oriented Clinical Outcome	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.

Trial Locations

Locations (7)

University Hospitals Bristol; 🇬🇧 Bristol, United Kingdom

Golden Jubilee; 🇬🇧 Glasgow, United Kingdom

Mater Private; 🇮🇪 Dublin, Ireland

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

Galway University Hospital; 🇮🇪 Galway, Ireland

Royal Edinburgh; 🇬🇧 Edinburgh, United Kingdom

St. George's Hospital; 🇬🇧 London, United Kingdom