GUIDEX® Versus Launcher™ Guiding Catheter in Percutaneous Coronary Intervention (PCI) (GUIDEX_FR) (GUIDEX®_FR)

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.

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:

• Aren't the safety of medical devices inferior to each other?
• Aren't the efficacyof medical devices inferior to each other? Participants will be randomized (1:1) and have a percutaneous coronary interventionwith one of the two guiding catheters.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: GUIDEX® guiding catheter; Device: Launcher™ coronary guide catheter

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, 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).

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clement Servoz, Dr; Phone Number: +33 5 61 32 24 31; Email: servoz.c@chu-toulouse.fr
• Study Contact Backup: Name: Thibault Lhermusier, Pr; Email: lhermusier.t@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31300
    • CHU Toulouse
    • Contact: Clement Servoz, Dr; Phone Number: +33 5 61 32 24 31; Email: servoz.c@chu-toulouse.fr
    • Contact: Thibault Lhermusier, Pr; Email: lhermusier.t@chu-toulouse.fr
    • Principal Investigator: Clement SERVOZ, Dr
    • Sub-Investigator: Thibault Lhermusier, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients need to be at least 18 years old.
• Patients with significant coronary artery disease who qualify for PCI (according to ACC/AHA/SCAI 2021 guidelines, including that the patient has received medical therapy with exercise and dietary recommendations before or at the same time as the PCI decision and that the clinical decision depends on the cardiology team) and who can be treated with a radial and femoral approach
• Patients scheduled for for Percutaneous Coronary Intervention and must remain overnight for observation
• The target vessel must have a TIMI flow 3 at baseline
• Palpable radial or fermoral artery
• Patients covered by the social security system

Exclusion Criteria:

• Concomitant use of Atherectomy, specialty balloon (intravascular lithotripsy), or investigational coronary devices (intravascular ultrasound, or optical coherence tomography)
• Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
• Prior PCI procedure within the last 30 days of the index procedure
• Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
• Uncontrolled severe hypertension (systolic BP >180 mm Hg or diastolic BP >110 mm Hg)
• Target vessel < 2.4 mm in diameter
• Target lesion > 32 mm in length
• Patient has allergy to imaging contrast media for which they cannot be pre-medicated
• Patients with hypersensitivity or contraindication to antiplatelet treatment
• Patient unable to stop his or her daily oral medication includes metformin treatment during 48 hours.
• Unstable patient: myocardial infarction, cardiogenic shock or with troponin above the upper limit of the normal laboratory value in the 24 hours prior to the procedure OR with elevated troponin and abnormal concomitant CK (non-exhaustive list).
• Unable to follow the requirements of the protocol.
• Vulnerable: whose ability or freedom to give or refuse consent is limited.
• Patients who cannot read or write french;
• Major protected by law (tutorship, curatorship, safeguarding justice...).
• Patient is pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous Coronary Intervention with Guiding Catheter GUIDEX; Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter	Device: GUIDEX® guiding catheter; The main steps of the procedure Percutaneous Coronary Intervention are : The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered.; The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques.; The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique.; The catheter should should address the selected vascular site; The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI.
Experimental: Percutaneous Coronary Intervention with Guiding Catheter Medtronics; Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter	Device: Launcher™ coronary guide catheter; The main steps of the procedure Percutaneous Coronary Intervention are : The patient should prepare for angioplasty using standard techniques. Appropriate anticoagulation and vasodilation therapy should be administered.; The Guiding Catheter must be introduced into the vascular system by cut-down or percutaneous techniques.; The guiding catheter will be introduce over a previously placed standard angiographic wire. It will be aspirate and flush after the removal of the angiographic wire following established angiographic technique.; The catheter should should address the selected vascular site; The guiding catheter will be removing. The procedure is performed in a healthcare facility, in an operating room under fluoroscopic monitoring. The users are trained practiticoners for PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: Cardiac death; Myocardial infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave; TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure	Baseline until the end of the procedure

Secondary Outcome Measures

Outcome Measure	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.	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: Cardiac death; Myocardial infarction - defined as a CK-MB level > 3 times the upper limit of lab normal (ULN) value with or without new pathologic Q wave; TVR - defined as revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure	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)

Collaborators and Investigators

• Sponsor: Tianjin Demax Medical Technology Co., Ltd
• Collaborators: CEISO

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Guiding catheter
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CLI-00910

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Nothing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No