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

Alvimedica Medical Technologies France1,030 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,030

Conditions

Diabetes Coronaropathy

Interventions

DES-CRE8DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Clinique de l'Europe

Amiens, France

Centre Hospitalier Avignon

Avignon, France

Outcomes

Primary Outcomes

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.

Time frame: 1 year post implantation

Secondary Outcomes

Major Adverse Cardiac Events (MACE) at 1 year

MACE are defined as: revascularization of the target lesion, heart attack or cardiac deaths.

Time frame: 1 year

Non cardiac deaths at 1 year

Time frame: 1 year

Stent thrombosis at 1 year

Certain or probable stent thrombosis

Time frame: 1 year

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.

Time frame: 1 year

Non cardiac deaths at 1 year in the sub-group of patients with a short planned dual-therapy

Non cardiac deaths at 1 year

Time frame: 1 year

Stent thrombosis at 1 year in the sub-group of patients with a short planned dual-therapy

Certain or probable stent thrombosis

Time frame: 1 year

Data from ClinicalTrials.gov

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