Clinical trial NCT03842813: Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients
Official title: Safety and Performance Assessment of Coronary Drug-Eluting Stent CRE8 : Post-market Observationnal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Coronaropathy
Lead sponsor: Alvimedica Medical Technologies France
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2019-02-15
Enrollment: 1030
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint is Target Lesion Failure (TLF) rate at 1 year
timeFrame: 1 year post implantation
Secondary outcomes:
measure: Major Adverse Cardiac Events (MACE) at 1 year
timeFrame: 1 year
measure: Non cardiac deaths at 1 year
timeFrame: 1 year
measure: Stent thrombosis at 1 year
timeFrame: 1 year
measure: Major Adverse Cardiac Events (MACE) at 1 year in the sub-group of patients with a short planned dual-therapy
timeFrame: 1 year
measure: Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy
timeFrame: 1 year
measure: Stent thrombosis at 1 year in the sub-group of patients with a short planned dual-therapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Amiens
country: France
facility: Clinique de l'Europe
city: Avignon
country: France
facility: Centre Hospitalier Avignon
city: Beauvais
country: France
facility: Centre Hospitalier Beauvais
city: Bourg-en-Bresse
country: France
facility: Clinique Convert
city: Brive-la-Gaillarde
country: France
facility: Centre Hospitalier Brive
city: Chartres
country: France
facility: Centre Hospitalier Chartres
city: Colmar
country: France
facility: Hôpital Schweitzer
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud-Francilien
city: Dijon
country: France
facility: Hôpital Privé de Bourgogne
city: Eaubonne
country: France
facility: Hôpital Simone Veil
city: Essey-lès-Nancy
country: France
facility: Clinique Pasteur
city: Gonesse
country: France
facility: Centre Hospitalier Gonesse
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble
city: Haguenau
country: France
facility: Centre Hospitalier Haguenau
city: Lyon
country: France
facility: Centre Hospitalier Saint-Joseph Saint-Luc
city: Montauban
country: France
facility: Clinique Pont de Chaumes
city: Pau
country: France
facility: Centre Hospitalier Pau
city: Rouen
country: France
facility: Clinique Saint-Hilaire
city: Saint-Quentin
country: France
facility: Centre Hospitalier Saint-Quentin
city: Trélazé
country: France
facility: Clinique Saint-Joseph
city: Valence
country: France
facility: Centre Hospitalier Valence
city: Vannes
country: France
facility: Centre Hospitalier Vannes
Study officials:
affiliation: Alvimedica Medical France
name: Julien Vandenwildenberg
role: STUDY_CHAIR
References: