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

NOT YET RECRUITING

NCT06009757

NA

Sponsor: Tianjin Demax Medical Technology Co., Ltd

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 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.

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-08

Completion Date

2025-02

Last Updated

2024-07-03

Healthy Volunteers

No

Conditions

Coronary Artery Disease

Interventions

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.

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.

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

Locations (1)

CHU Toulouse

Toulouse, France

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