- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03842813
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
Collaborators
Investigators
- Study Chair: Julien Vandenwildenberg, Alvimedica Medical France
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Diabetes
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Northern Care Alliance NHS Foundation TrustBrighter ABCompletedDiabetes type1 | Diabetes type2United Kingdom
-
VeraLight, Inc.InLight SolutionsUnknownGestational Diabetes | Insulin Dependent Diabetes | Non Insulin Dependent DiabetesUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
Oregon State UniversitySanofiCompletedType I or Type II Diabetes (Excludes Gestational Diabetes)
-
Taichung Veterans General HospitalNational Health Research Institutes, TaiwanRecruitingDiabetes Complications | Type 2 Diabetes | Maturity-Onset Diabetes of the Young (MODY)Taiwan
-
University of RoehamptonRecruitingType2 Diabetes Mellitus | Pre DiabetesUnited Kingdom
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
Clinical Trials on DES-CRE8
-
Korea University Anam HospitalDiomedicalRecruitingCoronary Artery Disease | Diabetes MellitusKorea, Republic of
-
Yonsei UniversityDioRecruitingCoronary Artery Disease | Drug Eluting StentKorea, Republic of
-
CID - Carbostent & Implantable DevicesCompletedStable Angina | Acute Myocardial Infarction | Unstable AnginaAustria, Italy, Netherlands, Belgium, Norway, Poland
-
UMC UtrechtUnknownAcute Coronary Syndrome | Stable Angina PectorisNetherlands, Luxembourg
-
Fondazione Evidence per Attività e Ricerche Cardiovascolari...Mediolanum Cardio ResearchCompletedMyocardial Infarction
-
Boston Scientific CorporationLabcoat, Ltd.Completed
-
I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioEnrolling by invitation
-
Henan Institute of Cardiovascular EpidemiologyRecruiting
-
Norfolk and Norwich University Hospitals NHS Foundation...University of East AngliaRecruiting
-
Istituto Clinico Sant'AmbrogioUnknownCoronary Artery DiseaseItaly