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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03842813

Acronym

EVALU8

Enrollment

1030

Registered

2019-02-15

Start date

2019-04-09

Completion date

2022-07-31

Last updated

2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronaropathy, Diabetes

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.

Interventions

DEVICEDES-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Non cardiac deaths at 1 year	1 year	Non cardiac deaths at 1 year
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 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026