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

July 2, 2024 updated by: Tianjin Demax Medical Technology Co., Ltd

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cardiovascular disease (CVD) remains the most common cause of death in the European region. In line with the Global Burden of Disease (GBD) estimates from 2001, 43% of all Cardio Vascular Disease (CVD) deaths are related to coronary artery disease (CAD).

Treatment of CAD is always based on medication, which may also be supplemented by invasive procedures. The most significant historical advances in the treatment of coronary artery disease were the development of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI).

An essential element in the success of an angioplasty and in shortening the procedure, the guiding catheter is not simply a support. While, it's primary role is designed to provide a pathway through which balloon dilation catheter, guide wire or other devices are introduced, it can also contribute to significant semantic information since it is the first tool to appear in the field of view. A variety of guiding catheter references are available on the market.

Guiding catheters of various sizes and shapes are selected based on vessel anatomy, lesion characteristics, vascular access and procedural complexity.

The GUIDEX® device is a guiding catheter designed to be used in percutaneous coronary intervention. GUIDEX® device is on the Chinese market since September 2015 (certificate renewal in 2020) and is presented for CE marking according to MDR 2017/745.

The aim of the study is to assess the essential requirements for CE marking of Guidex®: the efficacy and safety of the device. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Toulouse, France, 31300
        • Chu Toulouse
        • Contact:
        • Contact:
        • Principal Investigator:
          • Clement SERVOZ, Dr
        • Sub-Investigator:
          • Thibault Lhermusier, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Percutaneous Coronary Intervention with Guiding Catheter GUIDEX
Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter
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.
Experimental: Percutaneous Coronary Intervention with Guiding Catheter Medtronics
Patients with coronary artery disease during a percutaneous coronary intervention will be treated with one of the guiding catheter
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary outcome is the frequency of in-hospital major adverse cardiac events (MACE)
Time Frame: Baseline until the end of the procedure

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of subjects achieving angiographic with sucess
Time Frame: Baseline until End of the procedure
The percentage of subjects achieving angiographic success were defined as success in facilating delivery of the balloon dilation catheter, guidewire or other devices introduced in the coronary arteries, using the medical devices with <50% residual stenosis without serious angiographic complications. Serious angiographic complications defined as severe dissection (Type D to F - To confirm ), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
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.
Time Frame: Baseline until discharge from the hospital (Day 2)

Analyze the frequency of in-hospital major adverse cardiac events (MACE). 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 discharge from the hospital (Day 2)
Incidence of complication and adverse event rates
Time Frame: [Time frame; to the baseline up to 30 days after the procedure)
Incidence of adverse event during 1 month after the PCI (in particular related to the potential adverse event at the puncture site).
[Time frame; to the baseline up to 30 days after the procedure)
Time used for the procedure (in minutes) .
Time Frame: Baseline until end of the procedure (Day 1)
Time (in minutes) between the start of the procedure until the end of the procedure
Baseline until end of the procedure (Day 1)
Frequency of access-site-related complications.
Time Frame: Baseline until End of the procedure
The frequency of access-site related complications is defined as bleeding, pseudoaneurysm, arteriovenous fistula, and occlusion of the radial artery), which were considered to be major if they were associated with a vascular repair or a blood transfusion.
Baseline until End of the procedure
Frequency of access-site-related complications
Time Frame: Baseline until end of the procedure (Day 1)
Analyse the level of angulation of the coronary artery (in degrees) during the PCI
Baseline until end of the procedure (Day 1)
Assessed as Fluoroscopy time (in sec)
Time Frame: Baseline until end of the procedure (Day 1)
Assessed as fluoroscopy time (in sec) during the PCI
Baseline until end of the procedure (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Demax Medical Technology Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CEISO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLI-00910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Nothing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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