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

• Conditions: Diabetes; Coronaropathy

• Registration Number: NCT03842813
• Lead Sponsor: Alvimedica Medical Technologies France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Study Start: 2019-04-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10
• Primary Completion: 2022-02
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1030

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is Target Lesion Failure (TLF) rate at 1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (22)

Centre Hospitalier Pau; 🇫🇷 Pau, France

Hôpital Simone Veil; 🇫🇷 Eaubonne, France

Centre Hospitalier Gonesse; 🇫🇷 Gonesse, France

Clinique de l'Europe; 🇫🇷 Amiens, France

Clinique Convert; 🇫🇷 Bourg-en-Bresse, France

Centre Hospitalier Chartres; 🇫🇷 Chartres, France

Centre Hospitalier Beauvais; 🇫🇷 Beauvais, France

Hôpital Schweitzer; 🇫🇷 Colmar, France

Clinique Pasteur; 🇫🇷 Essey-lès-Nancy, France

Centre Hospitalier Saint-Quentin; 🇫🇷 Saint-Quentin, France

Centre Hospitalier Avignon; 🇫🇷 Avignon, France

Centre Hospitalier Brive; 🇫🇷 Brive-la-Gaillarde, France

Centre Hospitalier Sud-Francilien; 🇫🇷 Corbeil-Essonnes, France

Hôpital Privé de Bourgogne; 🇫🇷 Dijon, France

Centre Hospitalier Universitaire Grenoble; 🇫🇷 Grenoble, France

Centre Hospitalier Haguenau; 🇫🇷 Haguenau, France

Clinique Pont de Chaumes; 🇫🇷 Montauban, France

Clinique Saint-Hilaire; 🇫🇷 Rouen, France

Clinique Saint-Joseph; 🇫🇷 Trélazé, France

Centre Hospitalier Saint-Joseph Saint-Luc; 🇫🇷 Lyon, France

Centre Hospitalier Valence; 🇫🇷 Valence, France

Centre Hospitalier Vannes; 🇫🇷 Vannes, France