Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients (EVALU8)

Safety and Performance Assessment of Coronary Drug-Eluting Stent CRE8 : Post-market Observationnal Study

The study is a 'real-world' study which evaluates the safety and performance of the coronary DES-CRE8 in diabetic patients.

As routine care, each patient will be followed until 12 months after stent implantation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1030

Contacts and Locations

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

Study Locations

      • Amiens, France, 80090
        • Clinique de l'Europe
      • Avignon, France, 84902
        • Centre Hospitalier Avignon
      • Beauvais, France, 60000
        • Centre Hospitalier Beauvais
      • Bourg-en-Bresse, France, 01004
        • Clinique Convert
      • Brive-la-Gaillarde, France, 19100
        • Centre Hospitalier Brive
      • Chartres, France, 280018
        • Centre Hospitalier Chartres
      • Colmar, France, 68003
        • Hôpital Schweitzer
      • Corbeil-Essonnes, France, 91106
        • Centre Hospitalier Sud-Francilien
      • Dijon, France, 21000
        • Hôpital Privé de Bourgogne
      • Eaubonne, France, 95602
        • Hôpital Simone Veil
      • Essey-lès-Nancy, France, 54270
        • Clinique Pasteur
      • Gonesse, France, 95500
        • Centre Hospitalier Gonesse
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire Grenoble
      • Haguenau, France, 67500
        • Centre Hospitalier Haguenau
      • Lyon, France, 69365
        • Centre Hospitalier Saint-Joseph Saint-Luc
      • Montauban, France, 82000
        • Clinique Pont de Chaumes
      • Pau, France, 64000
        • Centre Hospitalier Pau
      • Rouen, France, 76000
        • Clinique Saint-Hilaire
      • Saint-Quentin, France, 02321
        • Centre Hospitalier Saint-Quentin
      • Trélazé, France, 49800
        • Clinique Saint-Joseph
      • Valence, France, 26000
        • Centre Hospitalier Valence
      • Vannes, France, 56017
        • Centre Hospitalier Vannes

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participation to the study will be proposed to all diabetic patients corresponding to the inclusion and exclusion criteria after implantation of one or more coronary stent CRE8.

Patients will be consecutively included to limit selection bias.

Description

Inclusion Criteria:

  • ≥18 years old,
  • patient informed and agreed to participate,
  • patient with one or more lesions treated with one or more coronary stent CRE8,
  • patient with a diabete insulin dependent or non-insulin dependant.

Exclusion Criteria:

  • pregnant or breast-feading women,
  • patient who refused to participate,
  • patient with another lesion treated during the same intervention with a balloon alone or with another stent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint is Target Lesion Failure (TLF) rate at 1 year
Time Frame: 1 year post implantation

The TLF is defined as cardiac deaths, heart attack in relation with the target vessel or revascularization of the target lesion.

If a patient has at least one of these events, he will be considered as TLF.

1 year post implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (MACE) at 1 year
Time Frame: 1 year
MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths.
1 year
Non cardiac deaths at 1 year
Time Frame: 1 year
Non cardiac deaths at 1 year
1 year
Stent thrombosis at 1 year
Time Frame: 1 year
Certain or probable stent thrombosis
1 year
Major Adverse Cardiac Events (MACE) at 1 year in the sub-group of patients with a short planned dual-therapy
Time Frame: 1 year
MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths.
1 year
Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy
Time Frame: 1 year
Non cardiac deaths at 1 year
1 year
Stent thrombosis at 1 year in the sub-group of patients with a short planned dual-therapy
Time Frame: 1 year
Certain or probable stent thrombosis
1 year

Collaborators and Investigators

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

Collaborators

Investigators

  • Study Chair: Julien Vandenwildenberg, Alvimedica Medical France

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 (ACTUAL)

April 9, 2019

Primary Completion (ANTICIPATED)

February 1, 2022

Study Completion (ANTICIPATED)

July 1, 2022

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (ACTUAL)

February 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2018-A02663-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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