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

NCT06009757 | Not Yet Recruiting DMC

• 1 other identifier: CLI-00910
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease

Keywords

Percutaneous coronary intervention; Guiding catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percentage of subjects achieving angiographic with sucess

  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.

  Baseline until discharge from the hospital (Day 2)

• Incidence of complication and adverse event rates

  [Time frame; to the baseline up to 30 days after the procedure)

• Time used for the procedure (in minutes) .

  Baseline until end of the procedure (Day 1)

• Frequency of access-site-related complications.

  Baseline until End of the procedure

Study Arms (2)

Percutaneous Coronary Intervention with Guiding Catheter GUIDEX

EXPERIMENTAL

Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter

Device: GUIDEX® guiding catheter

Percutaneous Coronary Intervention with Guiding Catheter Medtronics

EXPERIMENTAL

Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter

Device: Launcher™ coronary guide catheter

Interventions

GUIDEX® guiding catheter DEVICE

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.

Percutaneous Coronary Intervention with Guiding Catheter GUIDEX

Launcher™ coronary guide catheter DEVICE

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.

Percutaneous Coronary Intervention with Guiding Catheter Medtronics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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...).

Sponsors & Collaborators

• Tianjin Demax Medical Technology Co., Ltd: lead
• CEISO: collaborator

Study Sites (1)

CHU Toulouse

Toulouse, 31300, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Clement SERVOZ, Dr

CONTACT

+33 5 61 32 24 31; servoz.c@chu-toulouse.fr

Thibault Lhermusier, Pr

CONTACT

lhermusier.t@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The study is single-blind. The patient does not know which guidance catheter will be used. Due to the nature of the intervention (different form of guiding catheter), staff may not be blind to the allocation, but they are strongly encouraged not to disclose the participant's allocation status during follow-up assessments. The sponsor's team will not know what type of treatment the patient's number corresponds to. Under no circumstances will they have access to the list of matches between the patient number and the allocated treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: July 28, 2023
• First Posted: August 24, 2023
• Study Start: August 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: February 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)