Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06009757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-07-28
Brief Title:
GUIDEX Versus Launcher Guiding Catheter in Percutaneous Coronary Intervention PCI GUIDEX_FR
Sponsor:
Tianjin Demax Medical Technology Co Ltd
Organization:
DemaxGroup
Study Overview
Official Title:
Safety and Efficacy of the GUIDEX Versus Launcher Guiding Catheter in Adults Patients With Coronary Artery Disease CAD Requiring Percutaneous Coronary Intervention PCI a Non-inferiority and Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GUIDEX_FR
Brief Summary:
The goal of this clinical trial is to compare two guiding catheters in patients with coronary artery disease during a percutaneous coronary intervention between Guidex Guiding catheter DEMAX and Launcher coronary guide catheters Medtronic The main questions it aims to answer are
Arent the safety of medical devices inferior to each other
Arent the efficacyof medical devices inferior to each other Participants will be randomized 11 and have a percutaneous coronary interventionwith one of the two guiding catheters
Arent the safety of medical devices inferior to each other
Arent the efficacyof medical devices inferior to each other Participants will be randomized 11 and have a percutaneous coronary interventionwith one of the two guiding catheters
Detailed Description:
Cardiovascular disease CVD remains the most common cause of death in the European region In line with the Global Burden of Disease GBD estimates from 2001 43 of all Cardio Vascular Disease CVD deaths are related to coronary artery disease CAD
Treatment of CAD is always based on medication which may also be supplemented by invasive procedures The most significant historical advances in the treatment of coronary artery disease were the development of coronary artery bypass grafting CABG and percutaneous coronary intervention PCI
An essential element in the success of an angioplasty and in shortening the procedure the guiding catheter is not simply a support While its primary role is designed to provide a pathway through which balloon dilation catheter guide wire or other devices are introduced it can also contribute to significant semantic information since it is the first tool to appear in the field of view A variety of guiding catheter references are available on the market
Guiding catheters of various sizes and shapes are selected based on vessel anatomy lesion characteristics vascular access and procedural complexity
The GUIDEX device is a guiding catheter designed to be used in percutaneous coronary intervention GUIDEX device is on the Chinese market since September 2015 certificate renewal in 2020 and is presented for CE marking according to MDR 2017745
The aim of the study is to assess the essential requirements for CE marking of Guidex the efficacy and safety of the device Thus the aim of this non-inferiority study is to compare the efficacy and safety for patients with coronary artery disease during a percutaneous coronary intervention between Guidex Guiding catheter DEMAX and Launcher coronary guide catheters Medtronic
Treatment of CAD is always based on medication which may also be supplemented by invasive procedures The most significant historical advances in the treatment of coronary artery disease were the development of coronary artery bypass grafting CABG and percutaneous coronary intervention PCI
An essential element in the success of an angioplasty and in shortening the procedure the guiding catheter is not simply a support While its primary role is designed to provide a pathway through which balloon dilation catheter guide wire or other devices are introduced it can also contribute to significant semantic information since it is the first tool to appear in the field of view A variety of guiding catheter references are available on the market
Guiding catheters of various sizes and shapes are selected based on vessel anatomy lesion characteristics vascular access and procedural complexity
The GUIDEX device is a guiding catheter designed to be used in percutaneous coronary intervention GUIDEX device is on the Chinese market since September 2015 certificate renewal in 2020 and is presented for CE marking according to MDR 2017745
The aim of the study is to assess the essential requirements for CE marking of Guidex the efficacy and safety of the device Thus the aim of this non-inferiority study is to compare the efficacy and safety for patients with coronary artery disease during a percutaneous coronary intervention between Guidex Guiding catheter DEMAX and Launcher coronary guide catheters Medtronic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None