LiquID Safety Study - 200-0002
Research type
Research Study
Full title
LiquId Guide Catheter Extension Safety Study
IRAS ID
279733
Contact name
CHAD KUGLER
Contact email
Sponsor organisation
Seigla Medical, Inc.
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
This is a single arm, open label, multicenter study evaluating the patient incidence rate of in-hospital major adverse cardiac events when using the LiquId guide catheter extension in 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 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. This study is intended to support claims that the LiquId is safe and effective for its intended use.
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 45 subjects may be enrolled in the trial to obtain 34 evaluable cases. Enrollment will be stopped as soon as data from 34 clinical procedures using the LiquId are obtained.
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.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0138
Date of REC Opinion
30 Jun 2020
REC opinion
Further Information Favourable Opinion