Efficacy and Safety of Coronary Amphilimus-ELuting Stent in diAbeTic patiEnts (ESCALATE)

Ospedale S. Giovanni Bosco

Status: Unknown

Conditions: Coronary Artery Disease; Diabetes Mellitus

Study type: Observational

Funder types: Other

Identifiers

NCT03651180

14942

Details and patient eligibility

About

More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. However, to date there are no direct comparisons of these two type of drug eluting stents.

Full description

Drug eluting stent is the cornerstone of treatment in diabetic patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, there are a considerable number of patients who continue to have major adverse event despite this treatment. More recently a polymer-free drug eluting stent (Amphilimus eluting stent) has shown to have a superiority in terms of efficacy and safety if compared with stable polymer drug eluting stent when used in diabetic patients. These more favorable effects translate into reduced event rates, but to date there are no existing data comparing directly the mid-long term effect of this new polymer-free drug eluting stent with the other drug eluting stents in a larger cohort of patients.

Enrollment: 3,400 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of insulin or non-insulin dependent diabetes mellitus treated from at least 1 month
• if basal blood sugar at the admission is above 200 mg / dl or hemoglobin levels glycated> 6.5% (> 48 mmol / mol)

Exclusion criteria

• inability to provide informed consent or unable to guarantee the possibility of be contacted in the following 12 months;
• age under 18 years or over 80 years

Trial design

3,400 participants in 2 patient groups

Amphilimus eluting stent

Description:

Diabetic patients treated with Cre8 Amphilimus eluting stent

Non Amphilimus eluting stent

Description:

Diabetic patients treated with any other drug eluting stent