Safety and Performance Assessment of Drug-Eluting Stent CRE8 in Diabetic Patients (EVALU8)

Alvimedica

Status: Unknown

Conditions: Diabetes; Coronaropathy

Treatments: Device: DES-CRE8

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03842813

2018-A02663-52

Details and patient eligibility

About

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.

Enrollment: 1,030 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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