LiquID Guide Catheter Extension Safety Study 200-0004
Research type
Research Study
Full title
LiquId Guide Catheter Extension Safety Study
IRAS ID
315609
Contact name
Chad Kugler
Contact email
Sponsor organisation
Seigla Medical Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Research Summary
This is a single arm, open label, historically controlled, multicenter study evaluating the patient incidence rate of in-hospital major adverse cardiac events when using the LiquID Guide Catheter Extension device in percutaneous coronary interventions (PCI).
The purpose of this study is to provide initial clinical evidence to establish the safety and performance of the LiquID guide catheter extension in support of marketing the device for use in PCI. The LiquID guide catheter extension is a CE-marked unique guide extension device that optimizes the compatibility by working with a wider range of sizes of both guide catheters and therapeutic delivery catheters. It is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.
Subject population: Patients who are scheduled for percutaneous intervention to treat coronary artery disease who do not have significant comorbidities that might confound outcomes. Up to 95 subjects may be enrolled in the trial.
Follow-up: will consist of evaluation at 48 hours post-procedure or through patient discharge, whichever occurs first, and a follow-up telephone call 7-10 days post-procedure.
Study sites: 8 study sites (6 in UK, 2 in Ireland and 1 in Belgium).Summary of Results
The original purpose of this study was to provide initial clinical evidence to establish the safety and performance of the LiquID Guide Catheter Extension in support of post-market clinical follow-up (PMCF) for the device during use in PCI. Upon implementation of EU 2017/745, data from this study was then additionally to be used to establish safety and performance of the device under MDR.
Primary endpoint: In-hospital major adverse cardiac events (MACE) that occur within 48 hours post-procedure.
Secondary endpoint: Device Oriented Clinical Outcome (DOCE), defined as successful deployment and retrieval of the LiquID device.Up to 95 participants could be enrolled but enrollment was to be stopped as soon as data from 85 clinical procedures using the LiquID devices were obtained. Patient follow-up consisted of evaluation through patient discharge and a 7–10-day phone follow-up to assess for adverse events (AEs).
A total of 201 participants were screened at 8 clinical investigation sites. Of those, 115 were screen failures, resulting in a total of 86 participants treated using a LiquID device.
The LiquID Guide Catheter Extension Safety Study successfully met its primary endpoint with an in-hospital MACE rate of 2.3% (2/86). Along with the primary endpoint that demonstrates acceptable safety, the secondary endpoint of Device Oriented Clinical Outcome also shows acceptable clinical performance results compared to outcomes with similar devices in the clinical literature. No previously unidentified risks were found during the investigation.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
22/EM/0170
Date of REC Opinion
26 Sep 2022
REC opinion
Further Information Favourable Opinion