← Back to all trials
Completed
NCT06009757
GUIDEX® Versus Launcher™ Guiding Catheter in Percutaneous Coronary Intervention (PCI) (GUIDEX_FR)
Conditions: Coronary Artery Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Tianjin Demax Medical Technology Co., Ltd
Location: CHU Toulouse Toulouse
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.
Eligibility Criteria
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 \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
Source: ClinicalTrials.gov (NCT06009757). StuddyBuddy aggregates publicly available trial information.