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

• Conditions: Coronary Artery Disease; Diabetes Mellitus

• Registration Number: NCT03651180
• Lead Sponsor: Ospedale S. Giovanni Bosco

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-10
• Status Verified: 2018-08
• Study Start: 2018-08-01
• Study First Submitted QC: 2018-08-27
• Last Update Submitted: 2018-08-27
• Study First Posted: 2018-08-29
• Last Update Posted: 2018-08-29
• Primary Completion: 2020-10-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of the composite endpoint of cardiac death, definite and probable stent thrombosis, re-PCI, Target Vessel Revascularization and bleeding in the two groups of study	1 year	Evaluation and comparison of the composite endpont of cardiac death, definite and probable stent thrombosis according with Academic Research Consortium criteria, Re-PCI, Target Vessel Revascularization, Type III and V bleeding complications according with Bleeding Academic Research Consortium criteria in the two groups of study

Secondary Outcome Measures

Name	Time	Method
Incidence of every single adverse event (cardiac death, definite and probable stent thrombosis, re-PCI, Target Vessel Revascularization and bleeding) in the two groups of study	1 year	Measurements and comparison of the incidence of any single adverse event of the composite endpoint (cardiac death, definite and probable stent thrombosis according with Academic Research Consortium criteria, Re-PCI, Target Vessel Revascularization, Type III and V bleeding complications according with Bleeding Academic Research Consortium criteria) in the two groups of study

Trial Locations

Locations (1)

San Giovanni Bosco Hospital - ASL Città di Torino; 🇮🇹 Turin, Italy