UnknownNot Applicable

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

France1,030 participantsStarted 2019-04-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The primary endpoint is Target Lesion Failure (TLF) rate at 1 year

Timeframe: 1 year post implantation

Trial details

NCT IDNCT03842813

SponsorAlvimedica Medical Technologies France

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-02

View on ClinicalTrials.gov More Diabetes trials