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

Diabetes Clinical Trial

— EVALU8  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03842813
• Other study ID #: 2018-A02663-52
• Status: Active, not recruiting
• Start date: April 9, 2019
• Est. completion date: July 2022

Study information

• Verified date: May 2021
• Source: Alvimedica Medical Technologies France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1030
• Est. completion date: July 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronaropathy
• Diabetes

Intervention

Device:
• DES-CRE8
Polymer-free Amphilimus™ (Sirolimus + Fatty Acid) eluting coronary stent. The absence of the polymer minimizes the risk of inflammation/thrombosis, while the propriety formulation enhances drug absorption.

Locations

Country	Name	City	State
France	Clinique de l'Europe	Amiens
France	Centre Hospitalier Avignon	Avignon
France	Centre Hospitalier Beauvais	Beauvais
France	Clinique Convert	Bourg-en-Bresse
France	Centre Hospitalier Brive	Brive-la-Gaillarde
France	Centre Hospitalier Chartres	Chartres
France	Hôpital Schweitzer	Colmar
France	Centre Hospitalier Sud-Francilien	Corbeil-Essonnes
France	Hôpital Privé de Bourgogne	Dijon
France	Hôpital Simone Veil	Eaubonne
France	Clinique Pasteur	Essey-lès-Nancy
France	Centre Hospitalier Gonesse	Gonesse
France	Centre Hospitalier Universitaire Grenoble	Grenoble
France	Centre Hospitalier Haguenau	Haguenau
France	Centre Hospitalier Saint-Joseph Saint-Luc	Lyon
France	Clinique Pont de Chaumes	Montauban
France	Centre Hospitalier Pau	Pau
France	Clinique Saint-Hilaire	Rouen
France	Centre Hospitalier Saint-Quentin	Saint-Quentin
France	Clinique Saint-Joseph	Trélazé
France	Centre Hospitalier Valence	Valence
France	Centre Hospitalier Vannes	Vannes

Sponsors (2)

Lead Sponsor	Collaborator
Alvimedica Medical Technologies France	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is Target Lesion Failure (TLF) rate at 1 year	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	Major Adverse Cardiac Events (MACE) at 1 year	MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths.	1 year
Secondary	Non cardiac deaths at 1 year	Non cardiac deaths at 1 year	1 year
Secondary	Stent thrombosis at 1 year	Certain or probable stent thrombosis	1 year
Secondary	Major Adverse Cardiac Events (MACE) at 1 year in the sub-group of patients with a short planned dual-therapy	MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths.	1 year
Secondary	Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy	Non cardiac deaths at 1 year	1 year
Secondary	Stent thrombosis at 1 year in the sub-group of patients with a short planned dual-therapy	Certain or probable stent thrombosis	1 year