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| Name | Class |
|---|---|
| CEISO | INDUSTRY |
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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 question[s] it aims to answer are:
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, it's 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 2017/745.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Percutaneous Coronary Intervention with Guiding Catheter GUIDEX | Experimental | Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter |
|
| Percutaneous Coronary Intervention with Guiding Catheter Medtronics | Experimental | Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GUIDEX® guiding catheter | Device | The main steps of the procedure Percutaneous Coronary Intervention are :
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the frequency of in-hospital major adverse cardiac events (MACE) | Analyze the frequency of major adverse cardiac events (MACE) during the procedure. MACE was defined as the following:
| Baseline until the end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving angiographic with sucess | The percentage of subjects achieving angiographic success were defined as success in facilating delivery of the balloon dilation catheter, guidewire or other devices introduced in the coronary arteries, using the medical devices with <50% residual stenosis without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F - To confirm ), perforation, abrupt closure, and persistent slow flow or persistent no reflow. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clement SERVOZ, Dr | Contact | +33 5 61 32 24 31 | servoz.c@chu-toulouse.fr | |
| Thibault Lhermusier, Pr | Contact | lhermusier.t@chu-toulouse.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Toulouse | Toulouse | 31300 | France |
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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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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).
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The study is single-blind. The patient does not know which guidance catheter will be used.
Due to the nature of the intervention (different form of guiding catheter), staff may not be blind to the allocation, but they are strongly encouraged not to disclose the participant's allocation status during follow-up assessments. The sponsor's team will not know what type of treatment the patient's number corresponds to. Under no circumstances will they have access to the list of matches between the patient number and the allocated treatment.
|
| Launcher™ coronary guide catheter | Device | The main steps of the procedure Percutaneous Coronary Intervention are :
|
|
| Baseline until End of the procedure |
| Frequency of in-hospital major adverse cardiac events (MACE). MACE was defined as the following: a composite of cardiac death, myocardial infarction, and target lesion revascularization. | Analyze the frequency of in-hospital major adverse cardiac events (MACE). MACE was defined as the following:
| Baseline until discharge from the hospital (Day 2) |
| Incidence of complication and adverse event rates | Incidence of adverse event during 1 month after the PCI (in particular related to the potential adverse event at the puncture site). | [Time frame; to the baseline up to 30 days after the procedure) |
| Time used for the procedure (in minutes) . | Time (in minutes) between the start of the procedure until the end of the procedure | Baseline until end of the procedure (Day 1) |
| Frequency of access-site-related complications. | The frequency of access-site related complications is defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery), which were considered to be major if they were associated with a vascular repair or a blood transfusion. | Baseline until End of the procedure |
| Frequency of access-site-related complications | Analyse the level of angulation of the coronary artery (in degrees) during the PCI | Baseline until end of the procedure (Day 1) |
| Assessed as Fluoroscopy time (in sec) | Assessed as fluoroscopy time (in sec) during the PCI | Baseline until end of the procedure (Day 1) |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |