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

NCT06009757 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-03

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • CEISO

    collaborator INDUSTRY

  • Tianjin Demax Medical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-31
Primary Completion
2024-09-30
Completion
2025-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06009757 on ClinicalTrials.gov