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NCT06009757Completed

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

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
150 (actual)
First submitted
28 Jul 2023
Start date
10 Apr 2025
Primary completion date
6 Jan 2026
Lead sponsor
Tianjin Demax Medical Technology Co., Ltd
NCT number
NCT06009757

What you commit to

  • Study type: Interventional
  • Participants enrolled: 150
  • From 10 Apr 2025 to the primary completion date, 6 Jan 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant use of Atherectomy, specialty balloon (intravascular lithotripsy), or investigational coronary devices (intravascular ultrasound, or optical coherence tomography)
  • Prior PCI procedure within the last 30 days of the index procedure
  • Patient unable to stop his or her daily oral medication includes metformin treatment during 48 hours.

Other illness

  • Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
  • Uncontrolled severe hypertension (systolic BP \>180 mm Hg or diastolic BP \>110 mm Hg)
  • Patient has allergy to imaging contrast media for which they cannot be pre-medicated
  • Patients with hypersensitivity or contraindication to antiplatelet treatment

Lab values

  • Current platelet count \<100 x 10\^9cells/L or Hgb \<10 g/dL.
  • 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).

Other

  • Target vessel \< 2.4 mm in diameter
  • Target lesion \> 32 mm in length
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.